The Recall Desk
HighFDA (Devices)·Z-1229-2022·Announced 2022-06-15

Medical imaging software may display inaccurate measurement values

GE Healthcare's Centricity Universal Viewer Zero Footprint Client may display inaccurate distance and area measurements on magnified or scaled images.

What this means for you

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 Class II medical device recall. Although no illnesses or injuries have been reported, measurement inaccuracy in medical imaging software represents a risk of harm through potential diagnostic errors.

Plain-English summary

GE Healthcare has recalled the Centricity Universal Viewer Zero Footprint Client due to a software defect. The product consists of 488 units distributed worldwide and throughout the United States.

The defect involves measurement accuracy: When distance and area measurements are performed on magnified images, the software may display inaccurate measurement values. For this Zero Footprint Client product specifically, measurements may also be inaccurate when performed on lossy images that have been scaled down from their original resolution.

This Class II recall affects healthcare facilities and imaging centers worldwide and throughout the United States. Healthcare providers using this software should be aware of this potential measurement inaccuracy when relying on distance and area measurements for clinical purposes.

The recalled product

Product
Centricity Universal Viewer Zero Footprint Client
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging Software
Hazard
Affected units
488

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 (3)

  • Software Version 6.0 SP11 through 6.0 SP11.4
  • GTIN/DI: 00840682102988
  • Codes: 2089507-1XX

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Part of a larger recall action

This product is one of 5 recalled by GE Healthcare, 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 5 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · measurement inaccuracy

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