GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) 870 CZT O540+ Gantry 7.25mm: Catalog number H3906CW , UDI/DI 01008406821408432187CZ6304211200300, Serial Numbers: 87CZ63042; UDI/DI 01008406821408432187CA6305311210100, Serial Numbers: 87CA63053; UDI/DI 01008406821408432187CX6301111181000, Serial Numbers: 87CX63011; UDI/DI 01008406821408432187CY6302011190300, Serial Numbers: 87CY63020; UDI/DI 01008406821408432187CY6303511191100, Serial Numbers: 87CY63035; UDI/DI 01008406821408432187CZ6304011200100, Serial Numbers: 87CZ63040; UDI/DI 01008406821408432187CX6300411180700, Serial Numbers: 87CX63004; UDI/DI 01008406821408432187CX6300911180900, Serial Numbers: 87CX63009; UDI/DI 01008406821408432187CB6307211220700, Serial Numbers: 87CB63072; UDI/DI 01008406821408432187CA6306111211100, Serial Numbers: 87CA63061; UDI/DI 01008406821408432187CY6303211191000, Serial Numbers: 87CY63032; UDI/DI To be provided, Serial Numbers: 87CB63075, 87CA63058, 87CB63070, 87CB63069, 87CB63071, 87CB63077, 87CA63063, 87CB63064, 87CB63078, 87CA63062, 87CB63067, 87CA63057, 87CA63060, 87CB63065, 87CB63068, 87CB63074; UDI/DI Not Applicable, Serial Numbers: 87CY63019, 87CA63054, 87CZ63043, 87CA63055, 87CY63028, 87CY63037, 87CZ63044, 87CZ63045, 87CZ63048, 87CZ63041, 87CY63024, 87CY63017, 87CX63007, 87CX63008, 87CX63006, 87CX63014, 87CY63022, 87CX63015, 87CY63025, 87CX63010, 87CZ63052, 87CY63027, 87CY63026, 87CY63030, 87CZ63046, 87CX63013, 87CY63036, 87CZ63047, 87CY63033, 87CY63016, 87CX63005, 87CZ63039, 87CX63002, 87CX63012, 87CX63001, 87CY63023, 87CY63018; b) D670 CZT Gantry 7.25mm: Catalog number H3906DD, UDI/DI Not Applicable, Serial Numbers: CZGA55003, CZGA55004, CZGY55001; , UDI/DI To be provided, Serial Numbers: CZGB55006, CZGA55005, CZGB55007; c) DISCOV NM/CT 870 CZT: Catalog number H3906CW, UDI/DI 01008406821408432187CY6303811191200, Serial Numbers: 87CY63038; d) Discovery NMCT 670 CZT O540+: Catalog number H3906DD , UDI/DI Not Applicable, Serial Numbers: CZGZ55002; e) NM/CT 870 CZT CYBER DEFENCE: Catalog number H3906FK, UDI/DI To be provided, Serial Numbers: 87DB82001; f) NM/CT 870 CZT O540: Catalog number H3906CW , UDI/DI Not Applicable, Serial Numbers: 87CY63021, 87CZ63050, 87CZ63049, 87CZ63051, 87CY63034; g) NM/CT 870 CZT WSO: Catalog number 5376204-70-20, UDI/DI 01008406821408432187CA6305911210800, Serial Numbers: 87CA63059; UDI/DI 01008406821408432187CB6307611221000, Serial Numbers: 87CB63076; UDI/DI 01008406821408432187CB6307311220800, Serial Numbers: 87CB63073; : Catalog number H3906CW, UDI/DI To be provided, Serial Numbers: 87CB63066; : Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 87CA63056; h) NM/CT 870 CZT: Catalog number H3906CW, UDI/DI Not Applicable, Serial Numbers: 87CY63031; i) NM/CT 870 CZT O540+ 7.25MM: Catalog number H3906CV, UDI/DI 01008406821408432187CX6300311180700, Serial Numbers: 87CX63003; UDI/DI 01008406821408432187CY6302911190800, Serial Numbers: 87CY63029
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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 MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Reason for Recall:
- A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System
Product Codes/Lot Numbers:
a) 870 CZT O540+ Gantry 7.25mm: Catalog number H3906CW , UDI/DI 01008406821408432187CZ6304211200300, Serial Numbers: 87CZ63042; UDI/DI 01008406821408432187CA6305311210100, Serial Numbers: 87CA63053; UDI/DI 01008406821408432187CX6301111181000, Serial Numbers: 87CX63011; UDI/DI 01008406821408432187CY6302011190300, Serial Numbers: 87CY63020; UDI/DI 01008406821408432187CY6303511191100, Serial Numbers: 87CY63035; UDI/DI 01008406821408432187CZ6304011200100, Serial Numbers: 87CZ63040; UDI/DI 01008406821408432187CX6300411180700, Serial Numbers: 87CX63004; UDI/DI 01008406821408432187CX6300911180900, Serial Numbers: 87CX63009; UDI/DI 01008406821408432187CB6307211220700, Serial Numbers: 87CB63072; UDI/DI 01008406821408432187CA6306111211100, Serial Numbers: 87CA63061; UDI/DI 01008406821408432187CY6303211191000, Serial Numbers: 87CY63032; UDI/DI To be provided, Serial Numbers: 87CB63075, 87CA63058, 87CB63070, 87CB63069, 87CB63071, 87CB63077, 87CA63063, 87CB63064, 87CB63078, 87CA63062, 87CB63067, 87CA63057, 87CA63060, 87CB63065, 87CB63068, 87CB63074; UDI/DI Not Applicable, Serial Numbers: 87CY63019, 87CA63054, 87CZ63043, 87CA63055, 87CY63028, 87CY63037, 87CZ63044, 87CZ63045, 87CZ63048, 87CZ63041, 87CY63024, 87CY63017, 87CX63007, 87CX63008, 87CX63006, 87CX63014, 87CY63022, 87CX63015, 87CY63025, 87CX63010, 87CZ63052, 87CY63027, 87CY63026, 87CY63030, 87CZ63046, 87CX63013, 87CY63036, 87CZ63047, 87CY63033, 87CY63016, 87CX63005, 87CZ63039, 87CX63002, 87CX63012, 87CX63001, 87CY63023, 87CY63018; b) D670 CZT Gantry 7.25mm: Catalog number H3906DD, UDI/DI Not Applicable, Serial Numbers: CZGA55003, CZGA55004, CZGY55001; , UDI/DI To be provided, Serial Numbers: CZGB55006, CZGA55005, CZGB55007; c) DISCOV NM/CT 870 CZT: Catalog number H3906CW, UDI/DI 01008406821408432187CY6303811191200, Serial Numbers: 87CY63038; d) Discovery NMCT 670 CZT O540+: Catalog number H3906DD , UDI/DI Not Applicable, Serial Numbers: CZGZ55002; e) NM/CT 870 CZT CYBER DEFENCE: Catalog number H3906FK, UDI/DI To be provided, Serial Numbers: 87DB82001; f) NM/CT 870 CZT O540: Catalog number H3906CW , UDI/DI Not Applicable, Serial Numbers: 87CY63021, 87CZ63050, 87CZ63049, 87CZ63051, 87CY63034; g) NM/CT 870 CZT WSO: Catalog number 5376204-70-20, UDI/DI 01008406821408432187CA6305911210800, Serial Numbers: 87CA63059; UDI/DI 01008406821408432187CB6307611221000, Serial Numbers: 87CB63076; UDI/DI 01008406821408432187CB6307311220800, Serial Numbers: 87CB63073; : Catalog number H3906CW, UDI/DI To be provided, Serial Numbers: 87CB63066; : Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 87CA63056; h) NM/CT 870 CZT: Catalog number H3906CW, UDI/DI Not Applicable, Serial Numbers: 87CY63031; i) NM/CT 870 CZT O540+ 7.25MM: Catalog number H3906CV, UDI/DI 01008406821408432187CX6300311180700, Serial Numbers: 87CX63003; UDI/DI 01008406821408432187CY6302911190800, Serial Numbers: 87CY63029
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1057-2023
Related Recalls
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).
SMV DSI, System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.