The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0138-2024·Announced 2023-11-01

Radiological Imaging Software May Display Images from Multiple Patients in Single Study

GE Healthcare is recalling Centricity PACS-IW radiological imaging software versions V3.7.x through 3.7.3.9 SP3 because images from different patients may appear together in a single study, risking patient misidentification.

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 recall of medical device software where patient images from different individuals may be stored together in a single study, creating significant risk of patient data misidentification. No injuries or illnesses have been reported, and the hazard is currently theoretical without confirmed patient harm, placing it at Score 3 per the rubric for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare is recalling Centricity PACS-IW radiological image processing system software, versions V3.7.x through 3.7.3.9 SP3, as well as Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.

The defect is that images from two different patients may be contained in a single study when stored in the affected software versions. This cross-contamination of patient images creates a risk that images may be associated with the wrong patient record, potentially leading to diagnostic error or patient misidentification.

A total of 149 units have been distributed in the United States and internationally, including Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, France, Germany, India, Ireland, Italy, Kuwait, Malaysia, Netherlands, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, Uruguay, Venezuela, and Vietnam.

The recalled product

Product
Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System
Manufacturer
GE Healthcare
Category
Medical Device — Radiological Imaging Software
Hazard
Affected units
149

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)

  • UDI/DI none
  • Installed Product ID #: 101792-1-Centricity PACS-IW-00558370
  • 4345-1-Centricity PACS-IW-00558548
  • 12830-1-Centricity PACS-IW-00558312
  • 4378-1-Centricity PACS-IW-00558498
  • 100663-1-Centricity PACS-IW-00558514
  • 100858-1-Centricity PACS-IW-00558426
  • 100702-1-Centricity PACS-IW-00558539
  • 4109-1-Centricity PACS-IW-00558389
  • 101625-1-Centricity PACS-IW-00558531
  • 4593-1-Centricity PACS-IW-00558488
  • 100009-1-Centricity PACS-IW-00558560
  • 100838-1-Centricity PACS-IW-00558532
  • 4300-1-Centricity PACS-IW-00558207
  • 4294-1-Centricity PACS-IW-00558379
  • 13039-1-Centricity PACS-IW-00558385
  • 13102-1-Centricity PACS-IW-00558512
  • 4694-1-Centricity PACS-IW-00558556
  • 101742-1-Centricity PACS-IW-00558470
  • 101883-1-Centricity PACS-IW-00558487

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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