GE Healthcare Recalls Merge Mammo Workstation Software Due to Image Display Errors
GE Healthcare is recalling 28 units of Merge Mammo software version 8.0.2 because images may display out of sync with the navigator, potentially leading to misdiagnosis.
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 device) where injury (misdiagnosis) has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare is recalling 28 units of the Merge Mammo multi-modality digital mammography workstation, specifically software version 8.0.2. The recall is due to a potential safety issue where the Merge Mammo viewer can load and display images that are not in sync with the selected or highlighted images in the thumbnail navigator.
This incorrect image display issue could result in an inaccurate reading on the workstation. The source text notes that this could result in a missed intervention or mis-diagnosis. The affected units were distributed worldwide, including in the United States (specifically AK, AR, CA, IA, ID, IL, MI, MS, MT, NJ, NV, NY, OR, PA, SC, TN, and WI) and internationally to Israel, Mexico, and Spain.
The source text does not provide specific instructions for consumers or healthcare providers on how to resolve the issue, nor does it report any specific illnesses or injuries resulting from this defect.
The recalled product
- Product
- Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT.
- Manufacturer
- GE Healthcare It
- Affected units
- 28
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)
- Software version 8.0.2
Distribution
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