🔍 RecallPedia

Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.

Class I - Dangerous
🏥 Medical Devices Recalled: October 11, 2018 GE Healthcare Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    06051-Centricity Universal Viewer-00115203 06051PAC04; 102278-1-Centricity Universal Viewer-00558682 1-644600677; 102359-1-Centricity Universal Viewer-00558696 1-473998727; 102406-2-Centricity Universal Viewer-00558111 1-661827397; 102406-2-Centricity Universal Viewer-00558686 1-750710672; 102406-2-Centricity Universal Viewer-00558692 1-682147792; 102406-2-Centricity Universal Viewer-00558707 1-802428413; 103090-2-Centricity Universal Viewer-00546048 303715CVUWTSW; 104336-1-Centricity Universal Viewer-00346858 918277CVUWBSW; 13296-1-Centricity Universal Viewer-01364047 LCSH01364047; 1472-15-Centricity Universal Viewer-01367676 210875CAUVSW; 190171-Centricity Universal Viewer-00044015 190171ST05; 2440-1-Centricity Universal Viewer-00558701 PACS-IW-150; 282927-Centricity Universal Viewer-01806769 416813TESTRPACSUV; 300013-Centricity Universal Viewer-00156933 300013ST22; 329052-Centricity Universal Viewer-01443407 HCIT4270016UV; 339734-Centricity PACS-IW-01444878 HCIT4114402PIW;¿ 34381-Centricity Universal Viewer-00116124 34381PAC04; 34381-Centricity Universal Viewer-01980265 Installation tracked via Service Cloud Installed Product ID.; 4271-1-Centricity Universal Viewer-00558351 PACS-IW-129; 4289-1-Centricity Universal Viewer-00558459 PACS-IW-352; 4325-51-Centricity Universal Viewer-00599129 1-592001096; 4325-51-Centricity Universal Viewer-00599129 1-592001096; 4406-1-Centricity Universal Viewer-00558683 PACS-IW-323; 4491-1-Centricity Universal Viewer-00558690 PACS-IW-253; 48010-Centricity Universal Viewer-01444602 48010PAC04; 53008-Centricity Universal Viewer-00116118 53008PAC03; 81111-Centricity Universal Viewer-01286673 81111DBS01; 899010-Centricity Universal Viewer-01300907 Installation tracked via Service Cloud Installed Product ID.; 899010-Centricity Universal Viewer-01300907 Installation tracked via Service Cloud Installed Product ID.; 9752-1-Centricity Universal Viewer-00558454 PACS-IW-288; 9796-1-Centricity Universal Viewer-00558571 1-368083413; A54120-Centricity Universal Viewer-00040449 A5412010; A54852-Centricity Universal Viewer-00043560 A5485262 / A5485266 / A5485267 / A5485269 / A5485270 / A5485271; A91901-Centricity Universal Viewer-00044549 A9190177; A91901-Centricity Universal Viewer-01509889 A9190177; AMS39-Centricity Universal Viewer-00545606 AMS3963; AMS39-Centricity Universal Viewer-00545606 AMS3963; BON01-Centricity Universal Viewer-00044131 BON0164; ECT02-Centricity Universal Viewer-00059842 ECT0265; FP5028-Centricity Universal Viewer-00110911 FP502804; GH1077-Centricity Universal Viewer-01724675 GH1077UV01 Installation tracked via System ID. 4435495-1 Installation tracked via System ID. HCIT4270016UV¿ Installation tracked via System ID. HN-NA¿ Installation tracked via System ID. HCIT4220435UV Installation tracked via System ID. HCIT4264206UW¿; M15393-Centricity Universal Viewer-00043611 M1539319 / M1539321 / M1539322; M232471-Centricity Universal Viewer-00043629 M23247104; M41870-Centricity Universal Viewer-00043721 M4187019 /M4187021 / M4187022; M41913-Centricity Universal Viewer-00065993 M4191318 / M4191319; M41980-Centricity Universal Viewer-00044515 M41980107; M42073-Centricity Universal Viewer-00044530 M4207315; M42176-Centricity Universal Viewer-00043763 M4217634 / M4217636 / M4217628; M42176-Centricity Universal Viewer-00043763 M4217634 / M4217636 / M4217628; M44599-Centricity Universal Viewer-00043784 M4459914 / M4459916 / M4459917; M44875-Centricity Universal Viewer-00043829 M4487535; M44877-Centricity Universal Viewer-00043766 M4217637 / M4487710; M44997-Centricity Universal Viewer-00397920 M44997011; M45006-Centricity Universal Viewer-00043854 M4500623 / M4500625 / M4500626; PL1124-Centricity Universal Viewer-00038795 PL1124RW01; PL2970-Centricity Universal Viewer-00038797 PL2970RW01; PL3249-Centricity Universal Viewer-00038866 PL3249RW02; PL3277-Centricity Universal Viewer-00038831 PL3277RW01; PX4900-Centricity Universal Viewer-01369835 PX4900SV02; SA1339-Centricity Universal Viewer-00116444 Installation tracked via Service Cloud Installed Product ID; X1413856-Centricity Universal Viewer-00044474 X141385617; X1982342-Centricity Universal Viewer-00043950 X198234211 / X198234210; X3141198-Centricity Universal Viewer-00043959 X314119802; YP3150-Centricity Universal Viewer-01639018 Installation tracked via Service Cloud Installed Product ID.; ZA00113-Centricity Universal Viewer-01474463 ZA2990PP02; ZA1058-Centricity Universal Viewer-01724673 ZA1058UV01; and ZA2551-Centricity Universal Viewer-00116834 ZA2551PAC1.
  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:
Synchronization failure
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.

Product Codes/Lot Numbers:

06051-Centricity Universal Viewer-00115203 06051PAC04; 102278-1-Centricity Universal Viewer-00558682 1-644600677; 102359-1-Centricity Universal Viewer-00558696 1-473998727; 102406-2-Centricity Universal Viewer-00558111 1-661827397; 102406-2-Centricity Universal Viewer-00558686 1-750710672; 102406-2-Centricity Universal Viewer-00558692 1-682147792; 102406-2-Centricity Universal Viewer-00558707 1-802428413; 103090-2-Centricity Universal Viewer-00546048 303715CVUWTSW; 104336-1-Centricity Universal Viewer-00346858 918277CVUWBSW; 13296-1-Centricity Universal Viewer-01364047 LCSH01364047; 1472-15-Centricity Universal Viewer-01367676 210875CAUVSW; 190171-Centricity Universal Viewer-00044015 190171ST05; 2440-1-Centricity Universal Viewer-00558701 PACS-IW-150; 282927-Centricity Universal Viewer-01806769 416813TESTRPACSUV; 300013-Centricity Universal Viewer-00156933 300013ST22; 329052-Centricity Universal Viewer-01443407 HCIT4270016UV; 339734-Centricity PACS-IW-01444878 HCIT4114402PIW;¿ 34381-Centricity Universal Viewer-00116124 34381PAC04; 34381-Centricity Universal Viewer-01980265 Installation tracked via Service Cloud Installed Product ID.; 4271-1-Centricity Universal Viewer-00558351 PACS-IW-129; 4289-1-Centricity Universal Viewer-00558459 PACS-IW-352; 4325-51-Centricity Universal Viewer-00599129 1-592001096; 4325-51-Centricity Universal Viewer-00599129 1-592001096; 4406-1-Centricity Universal Viewer-00558683 PACS-IW-323; 4491-1-Centricity Universal Viewer-00558690 PACS-IW-253; 48010-Centricity Universal Viewer-01444602 48010PAC04; 53008-Centricity Universal Viewer-00116118 53008PAC03; 81111-Centricity Universal Viewer-01286673 81111DBS01; 899010-Centricity Universal Viewer-01300907 Installation tracked via Service Cloud Installed Product ID.; 899010-Centricity Universal Viewer-01300907 Installation tracked via Service Cloud Installed Product ID.; 9752-1-Centricity Universal Viewer-00558454 PACS-IW-288; 9796-1-Centricity Universal Viewer-00558571 1-368083413; A54120-Centricity Universal Viewer-00040449 A5412010; A54852-Centricity Universal Viewer-00043560 A5485262 / A5485266 / A5485267 / A5485269 / A5485270 / A5485271; A91901-Centricity Universal Viewer-00044549 A9190177; A91901-Centricity Universal Viewer-01509889 A9190177; AMS39-Centricity Universal Viewer-00545606 AMS3963; AMS39-Centricity Universal Viewer-00545606 AMS3963; BON01-Centricity Universal Viewer-00044131 BON0164; ECT02-Centricity Universal Viewer-00059842 ECT0265; FP5028-Centricity Universal Viewer-00110911 FP502804; GH1077-Centricity Universal Viewer-01724675 GH1077UV01 Installation tracked via System ID. 4435495-1 Installation tracked via System ID. HCIT4270016UV¿ Installation tracked via System ID. HN-NA¿ Installation tracked via System ID. HCIT4220435UV Installation tracked via System ID. HCIT4264206UW¿; M15393-Centricity Universal Viewer-00043611 M1539319 / M1539321 / M1539322; M232471-Centricity Universal Viewer-00043629 M23247104; M41870-Centricity Universal Viewer-00043721 M4187019 /M4187021 / M4187022; M41913-Centricity Universal Viewer-00065993 M4191318 / M4191319; M41980-Centricity Universal Viewer-00044515 M41980107; M42073-Centricity Universal Viewer-00044530 M4207315; M42176-Centricity Universal Viewer-00043763 M4217634 / M4217636 / M4217628; M42176-Centricity Universal Viewer-00043763 M4217634 / M4217636 / M4217628; M44599-Centricity Universal Viewer-00043784 M4459914 / M4459916 / M4459917; M44875-Centricity Universal Viewer-00043829 M4487535; M44877-Centricity Universal Viewer-00043766 M4217637 / M4487710; M44997-Centricity Universal Viewer-00397920 M44997011; M45006-Centricity Universal Viewer-00043854 M4500623 / M4500625 / M4500626; PL1124-Centricity Universal Viewer-00038795 PL1124RW01; PL2970-Centricity Universal Viewer-00038797 PL2970RW01; PL3249-Centricity Universal Viewer-00038866 PL3249RW02; PL3277-Centricity Universal Viewer-00038831 PL3277RW01; PX4900-Centricity Universal Viewer-01369835 PX4900SV02; SA1339-Centricity Universal Viewer-00116444 Installation tracked via Service Cloud Installed Product ID; X1413856-Centricity Universal Viewer-00044474 X141385617; X1982342-Centricity Universal Viewer-00043950 X198234211 / X198234210; X3141198-Centricity Universal Viewer-00043959 X314119802; YP3150-Centricity Universal Viewer-01639018 Installation tracked via Service Cloud Installed Product ID.; ZA00113-Centricity Universal Viewer-01474463 ZA2990PP02; ZA1058-Centricity Universal Viewer-01724673 ZA1058UV01; and ZA2551-Centricity Universal Viewer-00116834 ZA2551PAC1.

Distribution:

Distributed in: CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, WV

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0375-2019

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.

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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.

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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.

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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.

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