The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1500-2023·Announced 2023-05-10

GE Healthcare radiological imaging system patient information mismatch

GE Healthcare's Centricity PACS-IW radiological imaging system can mismatch patient information when correcting study details. 17 units distributed worldwide are affected.

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 medical device recall. The hazard—patient data mismatch in a radiological imaging system—creates direct risk of patient harm by providing incorrect clinical information for diagnosis or treatment decisions.

Plain-English summary

GE Healthcare has identified an issue with Centricity PACS-IW with Universal Viewer, a radiological image processing system used in medical imaging. When correcting patient or study information, data from two different patients can become mismatched, potentially leading to incorrect clinical information being associated with the wrong patient.

The affected product includes seven model/catalog numbers (2066908-061, 2066908-077, 2066908-086, 2066908-111, 2066908-123, 2066908-136, and 2066908-150). A total of 17 units have been distributed worldwide.

Healthcare facilities using the affected systems should verify patient and study information for accuracy before using it for clinical decision-making. Users should contact GE Healthcare regarding corrective actions or remediation options for the affected devices.

The recalled product

Product
Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; Radiological Image Processing System
Manufacturer
GE Healthcare
Category
Medical Device — Medical Imaging / Radiology
Hazard
Affected units
17

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)

  • No UDI/DI for these products: a) 2066908-061
  • Product ID Numbers: HC3062-Centricity Universal Viewer-01462397
  • b) 2066908-077
  • Product ID Numbers: YP3150-Centricity Universal Viewer-01639018
  • c) 2066908-086
  • Product ID Numbers: 100707-1-Centricity Universal Viewer-00558649
  • 9842-4-Centricity Universal Viewer-19386293
  • d) 2066908-111
  • Product ID Numbers: 1045-1-Centricity Universal Viewer-00558651
  • 1045-1-Centricity Universal Viewer-19607785
  • e) 2066908-123
  • Product ID Numbers: 4705-1-Centricity Universal Viewer-02398923
  • f) 2066908-136
  • Product ID Numbers: 4723-1-Centricity Universal Viewer-02303576
  • 104648-2-Centricity Universal Viewer-02354806
  • 101272-1-Centricity Universal Viewer-00558671
  • ZA2533-Centricity Universal Viewer-00116577
  • 280801-Centricity Universal Viewer-19737221
  • g) 2066908-150
  • Product ID Numbers: 100759-1-Centricity Universal Viewer-02360986

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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