The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0374-2019·Announced 2018-11-14

GE Healthcare Recalls Centricity PACS-IW Software Due to Synchronization Failure

GE Healthcare is recalling 13 units of Centricity PACS-IW software due to a synchronization failure that may affect the display of medical images.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any injuries, illnesses, or deaths, and the hazard is a software synchronization failure rather than a direct physical injury mechanism.

Plain-English summary

GE Healthcare, LLC is recalling 13 units of Centricity PACS-IW with Universal Viewer version 5.0.x. This software is used to display medical images, including mammograms, and data from various imaging sources. The recall is being conducted because of a synchronization failure.

The affected units were distributed to facilities in California, Colorado, Delaware, Florida, Hawaii, New York, Oklahoma, Pennsylvania, South Dakota, Texas, Washington, Wisconsin, and West Virginia. The software was also distributed in Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, Ireland, Italy, Mexico, the Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and Turkey.

Healthcare facilities should contact GE Healthcare for instructions on how to resolve the synchronization failure. No specific instructions for end-users are provided in the source text, as the product is a professional medical device.

The recalled product

Product
Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging Software
Hazard
Affected units
13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • 102062-1-Centricity Universal Viewer-00558650/1-357058918
  • 102406-2-Centricity Universal Viewer-00558667/1-640193933
  • 102406-2-Centricity Universal Viewer-00558669/1-598891571
  • 102747-1-Centricity Universal Viewer-00558673 /1-626086029
  • 103246-1-Centricity Universal Viewer-00558668 / 1-681512983
  • 11580-1-Centricity Universal Viewer-00558646 / 1-417869653
  • 2403-7-Centricity Universal Viewer-00558347 1-283597082
  • 269338-Centricity Universal Viewer-01453050 /HCIT4331279PIW
  • 4284-1-Centricity Universal Viewer-00558672 / 1-308060186
  • 4424-2-Centricity Universal Viewer-01474435 / CONCORDIM01474435
  • Installation tracked via System ID. / HCIT4216808PIW
  • Installation tracked via System ID. / 2UA443117XAW
  • and X13479-Centricity Universal Viewer-00043936 / X1347906 / X1347909.

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 2 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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