🔍 RecallPedia

Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN DISPLAY KIT 11.X DANISH, TOUCHSCREEN DISPLAY KIT 11.X ESTONIAN, TOUCHSCREEN DISPLAY KIT 11.X ITALIAN, TOUCHSCREEN DISPLAY KIT 11.X NORWEGIAN. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

Class I - Dangerous
🏥 Medical Devices Recalled: September 27, 2018 GE Healthcare Patient Monitors Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number, UDI Number, (Serial Number): 2097673-001-US (4651698-1); 2097673-001-US (4651698-3); 2097673-001-US (4651698-4); 2097673-001-US (4651726-1); 2097673-001-US (4652206-1); 2097673-001-US (4652206-2); 2097673-001-US (4649618-1); 2097673-001-US (4649618-2); 2097673-001-US (4649618-3); 2097673-001-US (4649618-4); 2097673-001-US (4649618-5); 2097673-001-US (4653227-1); 2097673-001-US (4653227-2); 2097673-001-US (4653227-3); 2097673-001-US (5474296-1); 2097673-001-US (4652587-1); 2097673-001-US (4652587-2); 2097673-001-US (4652587-3); 2097673-001-US (4652587-4); 2097673-001-US (4652587-5); 2097673-001-US (4652587-6); 2097673-001-US (4632861-1); 2097673-001-US (4632861-2); 2097673-001-US (4632861-3); 2097673-001-US (4644953-1); 2097673-001 (5463757-1); 2097673-001 (5467309-16); 2097673-001 (5471699-1); 2097673-001 (5471699-2); 2097673-001 (5471699-3); 2097673-001 (5475515-1); 2097673-001 (5475515-2); 2097673-001 (5475516-1); 2097673-001 (5475516-10); 2097673-001 (5475516-2); 2097673-001 (5475516-3); 2097673-001 (5475516-4); 2097673-001 (5475516-5); 2097673-001 (5475516-6); 2097673-001 (5475516-7); 2097673-001 (5475516-8); 2097673-001 (5475516-9); 2097673-001 (5475528-1); 2097673-001 (5475528-10); 2097673-001 (5475528-11); 2097673-001 (5475528-12); 2097673-001 (5475528-13); 2097673-001 (5475528-14); 2097673-001 (5475528-15); 2097673-001 (5475528-16); 2097673-001 (5475528-17); 2097673-001 (5475528-18); 097673-001 (5475528-19); 2097673-001 (5475528-2); 2097673-001 (5475528-3); 2097673-001 (5475528-4); 2097673-001 (5475528-5); 2097673-001 (5475528-6); 2097673-001 (5475528-7); 2097673-001 (5475528-8); 2097673-001 (5475528-9); 2097673-001 (5481650-1); 2097673-001 (5481650-10); 2097673-001 (5481650-2); 2097673-001 (5481650-3); 097673-001 (5481650-4); 2097673-001 (5481650-5); 2097673-001 (5481650-6); 2097673-001 (5481650-7); 2097673-001 (5481650-8); 2097673-001 (5481650-9); 2097673-001 (5471701-1); 2097673-001 (5471701-2); 2097673-001 (5471702-1); 2097673-001 (5472013-1); 2097673-001 (5472013-10); 097673-001 (5472013-12); 2097673-001 (5472013-14); 2097673-001 (5472013-15); 2097673-001 (5472013-16); 2097673-001 (5472013-17); 2097673-001 (5472013-18); 2097673-001 (5472013-3); 2097673-001 (5472013-4); 2097673-001 (5472013-5); 2097673-001 (5472013-6); 2097673-001 (5472013-7); 2097673-001 (5472013-8); 2097673-001 (5463631-1); 2097673-001 (5463631-2); 2097673-001 (5466892-1); 2097673-001 (5466892-10); 2097673-001 (5466892-2); 2097673-001 (5466892-3); 2097673-001 (5466892-4); 2097673-001 (5466892-5); 2097673-001 (5466892-6); 2097673-001 (5466892-7); 2097673-001 (5466892-8); 2097673-001 (5466892-9); 2097673-DE (5480919-1); 2097673-NL (5473301-1); 2097673-NL (5473301-2); 2097673-NL (5473301-3); 2097673-NL (5473301-4); 2097673-NL (5473301-5); 2097673-NL (5473301-6); 2097673-FR (5481162-1); 2097673-NL (5481369-1); 2097673-NL (5481369-2); 2097673-NL (5481369-3); 2097673-NL (5481369-4); 2097673-NL (5481369-5); 2097673-NL (5481369-6); 2097673-NL (5481369-7); 2097673-NL (5481369-8); 2097673-NL (5481369-9); 2097673-001 (5462738-1); 2097673-001 (5462738-2); 2097673-FR (5475371-1); 2097673-FR (5475371-2); 2097673-FR (5475371-3); 2097673-FR (5475371-4); 2097673-FR (5475371-5); 2097673-FR (5479900-1); 2097673-DA (5453900-1); 2097673-ET (5461749-1); 2097673-FR (5481462-1); 2097673-FR (5481462-2); 2097673-FR (5481462-3); 2097673-FR (5481462-4); 2097673-FR (5481462-5); 2097673-FR (5481462-6); 2097673-FR (5481462-7); 2097673-FR (5481462-8); 2097673-FR (5481462-9); 2097673-FR (5473743-1); 2097673-FR (5473743-2); 2097673-FR (5473743-3); 2097673-FR (5473743-4); 2097673-FR (5473743-5); 2097673-FR (5473744-1); 2097673-FR (5473744-2); 2097673-FR (5473744-3); 2097673-FR (5473744-4); 2097673-FR (5473744-5); 2097673-FR (5473744-6); 2097673-FR (5458277-1); 2097673-FR (5458277-2); 2097673-001 (5455478-1); 2097673-IT (5476554-1); 2097673-IT (5476554-2); 2097673-IT (5476554-3); 2097673-NL (5450447-1); 2097673-NL (5450447-3); 2097673-NL (5450447-5); 2097673-NL (5450447-6); 2097673-NO (5474251-1); 2097673-001 (5476468-70); 2097673-001 (5476468-71); 2097673-001 (5476468-72); 2097673-001 (5476468-73); 2097673-001 (5476468-74); 2097673-001 (5476468-75); 2097673-001 (5476468-76); 2097673-001 (5476468-77); 2097673-001 (5476468-78); 2097673-001 (5476468-79); 2097673-001 (5476468-80); 2097673-001 (5476468-81); 2097673-001 (5476468-82); 2097673-001 (5476468-83); 2097673-001 (5476468-84); 2097673-001 (5476468-85); 2097673-001 (5476468-86); 2097673-001-US (4673852-1); 2097673-001-US (4673852-2); 2097673-001-US (4673852-3); Additional Serial Numbers - Model Number, UDI Number, (Serial Number): 2097673-001-US, Not Applicable, (ANAM00306); 2097673-001-US, Not Applicable, (ANAP00354); 2097673-001-US, Not Applicable, (APWU00297); 2097673-001-US, Not Applicable, (ANAP00715); 2097673-001-US, Not Applicable, (ANAR00602); 2097673-001-US, Not Applicable, (ANAR00603); 2097673-001-US, Not Applicable, (ANAN00169); 2097673-001-US, Not Applicable, (ANAP00574); 2097673-001-US, Not Applicable, (ANAP00575); 2097673-001-US, Not Applicable, (ANAP00576); 2097673-001-US, Not Applicable, (ANAP00577); 2097673-001-US, Not Applicable, (ANAQ01175); 2097673-001-US, Not Applicable, (ANAP00172); 2097673-001-US, Not Applicable, (ANAP00861); 2097673-001-US, Not Applicable, (ANAP00870); 2097673-001-US, Not Applicable, (ANAP00872); 2097673-001-US, Not Applicable, (ANAS00398 ); 2097673-001-US, Not Applicable, (ANAL00105); 2097673-001-US, Not Applicable, (ANAL00106); 2097673-001-US, Not Applicable, (ANAL00107); 2097673-001-US, Not Applicable, (ANAL00108); 2097673-001-US, Not Applicable, (ANAL00109); 2097673-001-US, Not Applicable, (ANAL00116); 2097673-001-US, Not Applicable, (ANAM00439); 2097673-001-US, Not Applicable, (ANAM00440); 2097673-001-US, Not Applicable, (ANAM00441); 2097673-001-US, Not Applicable, (ANAP01088); 2097673-001-US, Not Applicable, (ANAP01090); 2097673-001-US, Not Applicable, (ANAP01091); 2097673-001, Not Applicable, (ANAN00604); 2097673-001, Not Applicable, (ANAM01165); 2097673-001, Not Applicable, (ANAM01158); 2097673-001, Not Applicable, (ANAM00815); 2097673-001, Not Applicable, (ANAM00816); 2097673-001, Not Applicable, (ANAM00817); 2097673-001, Not Applicable, (ANAM00818); 2097673-001, Not Applicable, (ANAM00819); 2097673-001, Not Applicable, (ANAM00820); 2097673-001, Not Applicable, (ANAM00821); 2097673-001, Not Applicable, (ANAM00822); 2097673-001, Not Applicable, (ANAM00823); 2097673-001, Not Applicable, (ANAM00824); 2097673-DE, Not Applicable, (ANAP01156); 2097673-001, Not Applicable, (ANAR00318); 2097673-001, Not Applicable, (ANAR00319); 2097673-FR, Not Applicable, (ANAR05232); 2097673-FR, Not Applicable, (ANAR05233); 2097673-FR, Not Applicable, (ANAR05234); 2097673-FR, Not Applicable, (ANAR05235); 2097673-FR, Not Applicable, (ANAR05236); 2097673-FR, Not Applicable, (ANAP01419); 1011-9000-000, Not Applicable, (APWT00661); 1011-9000-000, Not Applicable, (APWT00662); 1011-9000-000, Not Applicable, (APWT00664); 1011-9000-000, Not Applicable, (ANAN00664); 1011-9000-000, Not Applicable, (ANAN00666); 1011-9000-000, Not Applicable, (ANAN00667); 1011-9000-000, Not Applicable, (ANAN00669); 1011-9000-000, Not Applicable, (ANAN00670); 1011-9000-000, Not Applicable, (ANAN00671); 1011-9000-000, Not Applicable, (ANAN00890); 1011-9000-000, Not Applicable, (ANAN00891); 1011-9000-000, Not Applicable, (ANAR00396); 1011-9000-000, Not Applicable, (APWT02012); 1011-9000-000, Not Applicable, (APWT02013); 1011-9000-000, Not Applicable, (ANAN01101); 1011-9000-000, Not Applicable, (ANAP00605); 2097673-FR, Not Applicable, (ANAQ00803); 2097673-FR, Not Applicable, (ANAQ00806); 2097673-FR, Not Applicable, (ANAQ00948); 2097673-FR, Not Applicable, (ANAR05145); 2097673-FR, Not Applicable, (ANAR05150); 2097673-FR, Not Applicable, (ANAR05513); 2097673-FR, Not Applicable, (ANAR05517); 2097673-FR, Not Applicable, (ANAS00665); 2097673-FR, Not Applicable, (ANAS00666); 2097673-FR, Not Applicable, (ANAS00668); 2097673-FR, Not Applicable, (ANAS00971); 2097673-NO, Not Applicable, (ANAQ01098);
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GE Healthcare, LLC
Reason for Recall:
Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN DISPLAY KIT 11.X DANISH, TOUCHSCREEN DISPLAY KIT 11.X ESTONIAN, TOUCHSCREEN DISPLAY KIT 11.X ITALIAN, TOUCHSCREEN DISPLAY KIT 11.X NORWEGIAN. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

Product Codes/Lot Numbers:

Model Number, UDI Number, (Serial Number): 2097673-001-US (4651698-1); 2097673-001-US (4651698-3); 2097673-001-US (4651698-4); 2097673-001-US (4651726-1); 2097673-001-US (4652206-1); 2097673-001-US (4652206-2); 2097673-001-US (4649618-1); 2097673-001-US (4649618-2); 2097673-001-US (4649618-3); 2097673-001-US (4649618-4); 2097673-001-US (4649618-5); 2097673-001-US (4653227-1); 2097673-001-US (4653227-2); 2097673-001-US (4653227-3); 2097673-001-US (5474296-1); 2097673-001-US (4652587-1); 2097673-001-US (4652587-2); 2097673-001-US (4652587-3); 2097673-001-US (4652587-4); 2097673-001-US (4652587-5); 2097673-001-US (4652587-6); 2097673-001-US (4632861-1); 2097673-001-US (4632861-2); 2097673-001-US (4632861-3); 2097673-001-US (4644953-1); 2097673-001 (5463757-1); 2097673-001 (5467309-16); 2097673-001 (5471699-1); 2097673-001 (5471699-2); 2097673-001 (5471699-3); 2097673-001 (5475515-1); 2097673-001 (5475515-2); 2097673-001 (5475516-1); 2097673-001 (5475516-10); 2097673-001 (5475516-2); 2097673-001 (5475516-3); 2097673-001 (5475516-4); 2097673-001 (5475516-5); 2097673-001 (5475516-6); 2097673-001 (5475516-7); 2097673-001 (5475516-8); 2097673-001 (5475516-9); 2097673-001 (5475528-1); 2097673-001 (5475528-10); 2097673-001 (5475528-11); 2097673-001 (5475528-12); 2097673-001 (5475528-13); 2097673-001 (5475528-14); 2097673-001 (5475528-15); 2097673-001 (5475528-16); 2097673-001 (5475528-17); 2097673-001 (5475528-18); 097673-001 (5475528-19); 2097673-001 (5475528-2); 2097673-001 (5475528-3); 2097673-001 (5475528-4); 2097673-001 (5475528-5); 2097673-001 (5475528-6); 2097673-001 (5475528-7); 2097673-001 (5475528-8); 2097673-001 (5475528-9); 2097673-001 (5481650-1); 2097673-001 (5481650-10); 2097673-001 (5481650-2); 2097673-001 (5481650-3); 097673-001 (5481650-4); 2097673-001 (5481650-5); 2097673-001 (5481650-6); 2097673-001 (5481650-7); 2097673-001 (5481650-8); 2097673-001 (5481650-9); 2097673-001 (5471701-1); 2097673-001 (5471701-2); 2097673-001 (5471702-1); 2097673-001 (5472013-1); 2097673-001 (5472013-10); 097673-001 (5472013-12); 2097673-001 (5472013-14); 2097673-001 (5472013-15); 2097673-001 (5472013-16); 2097673-001 (5472013-17); 2097673-001 (5472013-18); 2097673-001 (5472013-3); 2097673-001 (5472013-4); 2097673-001 (5472013-5); 2097673-001 (5472013-6); 2097673-001 (5472013-7); 2097673-001 (5472013-8); 2097673-001 (5463631-1); 2097673-001 (5463631-2); 2097673-001 (5466892-1); 2097673-001 (5466892-10); 2097673-001 (5466892-2); 2097673-001 (5466892-3); 2097673-001 (5466892-4); 2097673-001 (5466892-5); 2097673-001 (5466892-6); 2097673-001 (5466892-7); 2097673-001 (5466892-8); 2097673-001 (5466892-9); 2097673-DE (5480919-1); 2097673-NL (5473301-1); 2097673-NL (5473301-2); 2097673-NL (5473301-3); 2097673-NL (5473301-4); 2097673-NL (5473301-5); 2097673-NL (5473301-6); 2097673-FR (5481162-1); 2097673-NL (5481369-1); 2097673-NL (5481369-2); 2097673-NL (5481369-3); 2097673-NL (5481369-4); 2097673-NL (5481369-5); 2097673-NL (5481369-6); 2097673-NL (5481369-7); 2097673-NL (5481369-8); 2097673-NL (5481369-9); 2097673-001 (5462738-1); 2097673-001 (5462738-2); 2097673-FR (5475371-1); 2097673-FR (5475371-2); 2097673-FR (5475371-3); 2097673-FR (5475371-4); 2097673-FR (5475371-5); 2097673-FR (5479900-1); 2097673-DA (5453900-1); 2097673-ET (5461749-1); 2097673-FR (5481462-1); 2097673-FR (5481462-2); 2097673-FR (5481462-3); 2097673-FR (5481462-4); 2097673-FR (5481462-5); 2097673-FR (5481462-6); 2097673-FR (5481462-7); 2097673-FR (5481462-8); 2097673-FR (5481462-9); 2097673-FR (5473743-1); 2097673-FR (5473743-2); 2097673-FR (5473743-3); 2097673-FR (5473743-4); 2097673-FR (5473743-5); 2097673-FR (5473744-1); 2097673-FR (5473744-2); 2097673-FR (5473744-3); 2097673-FR (5473744-4); 2097673-FR (5473744-5); 2097673-FR (5473744-6); 2097673-FR (5458277-1); 2097673-FR (5458277-2); 2097673-001 (5455478-1); 2097673-IT (5476554-1); 2097673-IT (5476554-2); 2097673-IT (5476554-3); 2097673-NL (5450447-1); 2097673-NL (5450447-3); 2097673-NL (5450447-5); 2097673-NL (5450447-6); 2097673-NO (5474251-1); 2097673-001 (5476468-70); 2097673-001 (5476468-71); 2097673-001 (5476468-72); 2097673-001 (5476468-73); 2097673-001 (5476468-74); 2097673-001 (5476468-75); 2097673-001 (5476468-76); 2097673-001 (5476468-77); 2097673-001 (5476468-78); 2097673-001 (5476468-79); 2097673-001 (5476468-80); 2097673-001 (5476468-81); 2097673-001 (5476468-82); 2097673-001 (5476468-83); 2097673-001 (5476468-84); 2097673-001 (5476468-85); 2097673-001 (5476468-86); 2097673-001-US (4673852-1); 2097673-001-US (4673852-2); 2097673-001-US (4673852-3); Additional Serial Numbers - Model Number, UDI Number, (Serial Number): 2097673-001-US, Not Applicable, (ANAM00306); 2097673-001-US, Not Applicable, (ANAP00354); 2097673-001-US, Not Applicable, (APWU00297); 2097673-001-US, Not Applicable, (ANAP00715); 2097673-001-US, Not Applicable, (ANAR00602); 2097673-001-US, Not Applicable, (ANAR00603); 2097673-001-US, Not Applicable, (ANAN00169); 2097673-001-US, Not Applicable, (ANAP00574); 2097673-001-US, Not Applicable, (ANAP00575); 2097673-001-US, Not Applicable, (ANAP00576); 2097673-001-US, Not Applicable, (ANAP00577); 2097673-001-US, Not Applicable, (ANAQ01175); 2097673-001-US, Not Applicable, (ANAP00172); 2097673-001-US, Not Applicable, (ANAP00861); 2097673-001-US, Not Applicable, (ANAP00870); 2097673-001-US, Not Applicable, (ANAP00872); 2097673-001-US, Not Applicable, (ANAS00398 ); 2097673-001-US, Not Applicable, (ANAL00105); 2097673-001-US, Not Applicable, (ANAL00106); 2097673-001-US, Not Applicable, (ANAL00107); 2097673-001-US, Not Applicable, (ANAL00108); 2097673-001-US, Not Applicable, (ANAL00109); 2097673-001-US, Not Applicable, (ANAL00116); 2097673-001-US, Not Applicable, (ANAM00439); 2097673-001-US, Not Applicable, (ANAM00440); 2097673-001-US, Not Applicable, (ANAM00441); 2097673-001-US, Not Applicable, (ANAP01088); 2097673-001-US, Not Applicable, (ANAP01090); 2097673-001-US, Not Applicable, (ANAP01091); 2097673-001, Not Applicable, (ANAN00604); 2097673-001, Not Applicable, (ANAM01165); 2097673-001, Not Applicable, (ANAM01158); 2097673-001, Not Applicable, (ANAM00815); 2097673-001, Not Applicable, (ANAM00816); 2097673-001, Not Applicable, (ANAM00817); 2097673-001, Not Applicable, (ANAM00818); 2097673-001, Not Applicable, (ANAM00819); 2097673-001, Not Applicable, (ANAM00820); 2097673-001, Not Applicable, (ANAM00821); 2097673-001, Not Applicable, (ANAM00822); 2097673-001, Not Applicable, (ANAM00823); 2097673-001, Not Applicable, (ANAM00824); 2097673-DE, Not Applicable, (ANAP01156); 2097673-001, Not Applicable, (ANAR00318); 2097673-001, Not Applicable, (ANAR00319); 2097673-FR, Not Applicable, (ANAR05232); 2097673-FR, Not Applicable, (ANAR05233); 2097673-FR, Not Applicable, (ANAR05234); 2097673-FR, Not Applicable, (ANAR05235); 2097673-FR, Not Applicable, (ANAR05236); 2097673-FR, Not Applicable, (ANAP01419); 1011-9000-000, Not Applicable, (APWT00661); 1011-9000-000, Not Applicable, (APWT00662); 1011-9000-000, Not Applicable, (APWT00664); 1011-9000-000, Not Applicable, (ANAN00664); 1011-9000-000, Not Applicable, (ANAN00666); 1011-9000-000, Not Applicable, (ANAN00667); 1011-9000-000, Not Applicable, (ANAN00669); 1011-9000-000, Not Applicable, (ANAN00670); 1011-9000-000, Not Applicable, (ANAN00671); 1011-9000-000, Not Applicable, (ANAN00890); 1011-9000-000, Not Applicable, (ANAN00891); 1011-9000-000, Not Applicable, (ANAR00396); 1011-9000-000, Not Applicable, (APWT02012); 1011-9000-000, Not Applicable, (APWT02013); 1011-9000-000, Not Applicable, (ANAN01101); 1011-9000-000, Not Applicable, (ANAP00605); 2097673-FR, Not Applicable, (ANAQ00803); 2097673-FR, Not Applicable, (ANAQ00806); 2097673-FR, Not Applicable, (ANAQ00948); 2097673-FR, Not Applicable, (ANAR05145); 2097673-FR, Not Applicable, (ANAR05150); 2097673-FR, Not Applicable, (ANAR05513); 2097673-FR, Not Applicable, (ANAR05517); 2097673-FR, Not Applicable, (ANAS00665); 2097673-FR, Not Applicable, (ANAS00666); 2097673-FR, Not Applicable, (ANAS00668); 2097673-FR, Not Applicable, (ANAS00971); 2097673-NO, Not Applicable, (ANAQ01098);

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0413-2019

Related Recalls

GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.

GE Healthcare

Class I - Dangerous

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Feb 19, 2025 Infusion Pumps View Details →

GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-010; 13) 2109594-009; 14) 2109594-011; 15) K2090PS; 16) K2090PTED; 17) MANLEGACY114; 18) MANLEGACY64.

GE Healthcare

Class I - Dangerous

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Feb 19, 2025 Other Medical Devices View Details →

GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.

GE Healthcare

Class I - Dangerous

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Feb 19, 2025 Other Medical Devices View Details →