The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0721-2023·Announced 2022-12-28

Medical Imaging Software Update May Hide Patient Studies

After installing the IAS tool, Centricity PACS-IW Universal Viewer version 5.0 may hide some medical imaging studies without notification. Accessing hidden studies requires GE Healthcare assistance and may cause diagnostic delays.

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: This is an FDA Class II medical device recall affecting a diagnostic imaging system. Although no injuries have been reported, the potential for medical imaging studies to become inaccessible and require manufacturer assistance presents a risk of delayed diagnosis in a clinical context.

Plain-English summary

GE Medical Systems, LLC is recalling Centricity PACS-IW with Universal Viewer version 5.0, a medical imaging display system used to show patient imaging studies, including mammograms.

After installation of the IAS tool, some medical imaging studies may become hidden and inaccessible to users without notification. Accessing these hidden studies requires assistance from GE Healthcare, which can result in delays in reading and reviewing the studies.

The recalled software has been distributed nationwide and internationally. Users who have installed the IAS tool with Centricity PACS-IW Universal Viewer version 5.0 and notice that imaging studies are not visible should contact GE Healthcare for assistance in accessing the hidden studies.

The recalled product

Product
Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Medical Imaging / PACS
Hazard
Affected units
1

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 (1)

  • Installed Product ID: YP3150-Centricity Universal Viewer-01639018

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

Part of a larger recall action

This product is one of 2 recalled by GE Medical Systems, 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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