The Recall Desk
HighFDA (Devices)·Z-0375-2019·Announced 2018-11-14

GE Healthcare Recalls Centricity Universal Viewer Due to Synchronization Failure

GE Healthcare is recalling 73 Centricity Universal Viewer units because a synchronization failure may affect the display of medical images.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a synchronization failure in a medical imaging device, which poses a risk of harm to patients if images are not displayed correctly, although no specific injuries are reported in the source text.

Plain-English summary

GE Healthcare, LLC is recalling 73 units of the Centricity Universal Viewer with PACS-IW foundation 6.0.x. The recall is due to a synchronization failure that may affect the display of medical images and data from various imaging sources, including mammograms.

The affected units were distributed in the United States (CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, and WV) and internationally in Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, Ireland, Italy, Mexico, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and Turkey. The recall is classified as Class II by the FDA.

Healthcare facilities should contact GE Healthcare for instructions on how to resolve the synchronization issue. No specific consumer action is required for the general public, as this product is used in professional medical settings.

The recalled product

Product
Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging Software
Hazard
Affected units
73

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 (20)

  • 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
  • 4271-1-Centricity Universal Viewer-00558351 PACS-IW-129
  • 4289-1-Centricity Universal Viewer-00558459 PACS-IW-352

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 →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · software defect

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