The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0143-2024·Announced 2023-11-01

Medical imaging system may display wrong patient information

GE Healthcare's Universal Viewer Workflow Manager medical imaging software may show the wrong patient's information when third-party reporting applications are used. This data mismatch could cause confusion during medical procedures.

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 a risk-of-harm medical device where patient safety could be compromised by data integrity issues. While classified as FDA Class II, the source reports no hospitalizations, injuries, or illnesses, keeping the score at the maximum of 3 per the rubric.

Plain-English summary

GE Healthcare has recalled its Universal Viewer Workflow Manager medical imaging software system due to a potential patient data mismatch issue.

The software may display information from a different patient than what the medical Workflow Manager and Viewer show when a third-party reporting application is used to launch imaging exams. This discrepancy could occur because the third-party application and the imaging system may show different patient records simultaneously, creating a risk of confusion about whose data is being processed.

The recall affects 57 units nationwide in the United States and internationally. The affected software versions are 7.0 SP1.1, 7.0 SP1, 7.0 SP0.0.5, and 7.0 SP0.1.0, with all product IDs containing these software versions impacted.

Facilities using affected equipment should contact GE Healthcare for information about available remediation options and software updates.

The recalled product

Product
Universal Viewer Workflow Manager, Image processing radiological system
Manufacturer
GE Healthcare
Category
Medical Device — Medical imaging software
Hazard
Affected units
57

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 (5)

  • UDI/DI 00195278379610
  • Software versions 7.0 SP1.1
  • 7.0 SP1
  • 7.0 SP0.0.5
  • 7.0 SP0.1.0. All product IDs with an affected software version are impacted.

Distribution

Distributed nationwide across the United States.

The notice also names 25 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 →

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