GE Healthcare Recalls Centricity Universal Viewer Due to Inaccurate X-ray Measurements
GE Healthcare is recalling Centricity Universal Viewer versions 6.0 and higher because magnified projection X-ray images may display inaccurate distance measurements.
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: The recall involves a medical device with a defect that could lead to inaccurate clinical data (inaccurate distance measurements), representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
GE Healthcare is recalling Centricity Universal Viewer versions 6.0 and higher. The recall involves 5 units of the device, which is used to display medical images, including mammograms, and data from various imaging sources. The product was distributed worldwide, including in the United States and numerous international locations.
The recall was initiated because the device may display inaccurate distance measurements when viewing magnified projection X-ray images. This issue could affect the accuracy of data presented to trained professionals, such as radiologists and physicians, who use the system for medical imaging.
Consumers and healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue. The recall number is Z-0226-2016.
The recalled product
- Product
- The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locatio
- Manufacturer
- GE Healthcare
- Hazard
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 (1)
- 2088034-001 DVD UNIVERSAL VIEWER 6.0 - WEB CLIENT
Distribution
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.
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