GE Healthcare Recalls Centricity PACS-IW Due to Inaccurate X-Ray Measurements
GE Healthcare is recalling Centricity PACS-IW software because it may display inaccurate distance measurements for magnified projection X-ray 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: The recall involves a risk-of-harm product (medical imaging software) where inaccurate measurements could impact patient care, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
GE Healthcare is recalling Centricity PACS-IW with Universal Viewer, a medical device used to display medical images and data from various imaging sources. The recall affects Versions 5.0 SP2 and higher, with 1,052 units 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 system is typically used by trained professionals, including radiologists, physicians, nurses, and medical technicians, to view, communicate, process, and display images within the system or across computer networks.
Users of the affected software should contact GE Healthcare for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- The Centricity PACS-IW with Universal Viewer 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 lo
- 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)
- 2067131-001DVD UNIVERSAL VIEWER 5.0 - 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.
See all 2 products in this recall →Related recalls
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