The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1501-2023·Announced 2023-05-10

Medical Image Viewer May Mismatch Patient Study Records

GE Healthcare's Centricity Universal Viewer can mismatch patient information when correcting patient or study data, affecting 329 units distributed worldwide.

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: FDA Class II device with potential for patient data mismatching but no reported incidents of harm. Classified as High because this is a risk-of-harm medical device with a theoretical hazard, meeting the rubric criterion where injury has not yet been reported.

Plain-English summary

GE Healthcare has issued a recall for the Centricity Universal Viewer, a radiological image processing system used for clinical imaging applications. The system is available in multiple model variants, with approximately 329 units distributed worldwide.

The recall has been issued because information from two different patients can be mismatched when correcting patient or study information. This occurs as a potential functionality issue within the system's patient information correction features.

Healthcare facilities and professionals using the Centricity Universal Viewer should contact GE Healthcare for guidance regarding this issue and any necessary corrective or mitigation measures.

The recalled product

Product
Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l)…
Manufacturer
GE Healthcare
Category
Medical Device — Radiological Imaging
Hazard
Affected units
329

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)

  • a) 2088026-003
  • No UDI/DI
  • Product ID numbers: 233637-Centricity Universal Viewer-15773152
  • b) 2088026-026
  • Product ID numbers: 4446-2-Centricity Universal Viewer-00558643
  • 4491-1-Centricity Universal Viewer-00558690
  • 100256-3-Centricity Universal Viewer-00558700
  • 100256-3-Centricity Universal Viewer-01810788
  • 102143-1-Centricity Universal Viewer-00558685
  • 101044-1-Centricity Universal Viewer-00558694
  • 13356-2-Centricity Universal Viewer-00558681
  • 102335-1-Centricity Universal Viewer-00558675
  • 13228-1-Centricity Universal Viewer-00558678
  • 101274-1-Centricity Universal Viewer-00558679
  • 101274-1-Centricity Universal Viewer-20279342
  • 13125-1-Centricity Universal Viewer-02268546
  • 102359-1-Centricity Universal Viewer-00558696
  • 4578-1-Centricity Universal Viewer-00558340
  • A54120-Centricity Universal Viewer-00040449
  • KW0000-Centricity Universal Viewer-01416913

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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