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.
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 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
- 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
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
See all →- HighGE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
- HighGE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
- HighGE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
- HighGE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
- SevereGE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
FDA (Devices) · 2022-07-27
Same hazard · measurement inaccuracy
See all →- HighCDI OneView System BPM Probe temperature sensor measurement inaccuracy
FDA (Devices) · 2025-07-02
- ModeratePhilips Tempus Pro Patient Monitor Software Update for Operational Issues
FDA (Devices) · 2025-05-14
- SevereVentilator Model LD2110X23B Recalled for Potential Sensor Measurement Failure
FDA (Devices) · 2024-11-20
- SevereAeris EVO Ventilator May Develop Flow Sensor Fouling from Aerosols
FDA (Devices) · 2024-11-20
- SevereTrilogy EV300 ventilator: potential flow sensor malfunction from aerosol accumulation
FDA (Devices) · 2024-11-20
Similar recalls
- HighGE Centricity Medical Imaging Software Displays Inaccurate Measurements
FDA (Devices) · 2022-07-13
- HighGE Centricity Medical Imaging Software May Display Incomplete Patient Studies
FDA (Devices) · 2021-12-08
- HighGE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
- HighGE Healthcare Recalls Centricity Universal Viewer Due to Inaccurate X-ray Measurements
FDA (Devices) · 2015-11-11
- HighGE radiology viewer may show patient information not matching displayed images
FDA (Devices) · 2026-03-11
- HighGE Healthcare Recalls Centricity Universal Viewer 6.0 for Measurement Errors
FDA (Devices) · 2020-01-29