The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2101-2018·Announced 2018-06-13

GE Healthcare Recalls Centricity PACS-IW Medical Image Viewer

GE Healthcare is recalling 44 units of the Centricity PACS-IW with Universal Viewer because image series may be missing without warning.

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 3/5 (High).

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 risk of harm (missing medical images) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

GE Healthcare is recalling 44 units of the Centricity PACS-IW with Universal Viewer. This medical device is used to display medical images, including mammograms, and data from various imaging sources. The recall covers units distributed worldwide, including in the United States and numerous international locations.

The recall was initiated because there is a potential that one or more image series may be missing from an exam without a user warning being displayed in the Viewer. This issue could affect the review of medical images by trained professionals, such as radiologists and physicians.

No specific instructions for consumers are provided in the source text, as the product is intended for use by trained medical professionals. The recall number is Z-2101-2018.

The recalled product

Product
Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and…
Manufacturer
GE Healthcare
Category
Medical Device — Medical Imaging
Hazard
Affected units
44

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)

  • 102747-1-Centricity Universal Viewer-00558673
  • 11580-1-Centricity Universal Viewer-00558646
  • 12945-1-Centricity Universal Viewer-00558658
  • 103852-1-Centricity Universal Viewer-00116028
  • 103246-1-Centricity Universal Viewer-00558668
  • 100707-1-Centricity Universal Viewer-00558649
  • 1045-1-Centricity Universal Viewer-00558651
  • 101725-2-Centricity Universal Viewer-00558642
  • 10227-1-Centricity Universal Viewer-00558665
  • 9768-1-Centricity Universal Viewer-00558661
  • 100019-1-Centricity Universal Viewer-00558666
  • 4284-1-Centricity Universal Viewer-00558672
  • 101272-1-Centricity Universal Viewer-00558671
  • 100862-1-Centricity Universal Viewer-01444483
  • 10278-1-Centricity Universal Viewer-00558655
  • 9789-1-Centricity Universal Viewer-00558645
  • 12914-1-Centricity Universal Viewer-00558660
  • 1696-1-Centricity Universal Viewer-00558659
  • 4408-1-Centricity Universal Viewer-00558664
  • 4410-1-Centricity Universal Viewer-00558656

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 2 recalled by GE Healthcare 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

See all →

Same hazard · missing data

See all →

Similar recalls