GE Centricity Medical Imaging Software Displays Inaccurate Measurements
GE Centricity Universal Viewer Zero Footprint software can display inaccurate measurements on medical images. This Class II recall affects approximately 1,934 units distributed worldwide.
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 Class II medical device recall involves software that may display inaccurate measurements on medical images. No illnesses or injuries are reported in the source, placing this risk-of-harm medical device recall at High severity per the rubric criterion for potential harm without documented injury.
Plain-English summary
GE Healthcare, LLC has recalled GE Centricity Universal Viewer Zero Footprint software (Versions 6.0 SP6 through SP11.4). This medical imaging software is used to view, process, and display medical images and data within computer networks and workstations.
The software can display inaccurate measurements when analyzing medical images. Inaccurate measurements could potentially lead to clinical errors if users rely on the displayed measurements for diagnostic or treatment decisions.
This Class II recall affects approximately 1,934 units distributed worldwide. GE Healthcare recommends users contact the company to obtain a software update. Detailed information about obtaining the patched version is available through the FDA recall notice.
The recalled product
- Product
- GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- inaccurate-measurement
- software-error
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 (2)
- UDI 00840682102988
- Versions 6.0 SP6 through SP11.4
Distribution
Distribution scope not specified by the agency.
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