The Recall Desk
HighFDA (Devices)·Z-0329-2022·Announced 2021-12-08

GE Centricity Medical Imaging Software May Display Incomplete Patient Studies

GE Healthcare recalled versions of Centricity Universal Viewer Zero Footprint Client software due to a potential defect that could display incomplete patient imaging studies. No injuries have been reported.

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: This FDA Class II recall involves a medical imaging software defect with potential to affect diagnostic accuracy. While no injuries or illnesses have been reported and the hazard is theoretical, incomplete patient imaging data poses a risk of patient harm through inaccurate diagnosis.

Plain-English summary

GE Healthcare, LLC has recalled the Centricity Universal Viewer Zero Footprint Client software, versions 6.0 SP9 through SP10.2.2.1 when configured with a Centricity PACS backend. A total of 638 devices have been affected. This medical imaging viewer is used in clinical settings worldwide.

The software has a potential defect that could cause it to display incomplete patient imaging studies. No injuries or illnesses related to this issue have been reported to date.

The affected software has been distributed worldwide, with use across the United States and in numerous other countries including Canada, Australia, the United Kingdom, France, Germany, Italy, Spain, and others.

The recalled product

Product
GE Centricity Universal Viewer Zero Footprint Client
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging Software
Hazard
Affected units
638

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 (15)

  • Versions 6.0 SP9
  • SP9.0.1
  • SP9.0.1.1
  • SP9.0.1.2
  • SP9.0.1.3
  • SP9.0.1.4
  • SP9.0.1.5
  • SP10
  • SP10.1
  • SP10.2
  • SP10.2.1
  • SP10.2.1.1
  • SP10.2.2
  • SP10.2.2.1 configured with a Centricity PACS back end. GTIN 00840682102988
  • UDI 00840682102988.

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

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