Merge PACS software recall for inconsistent mammography lesion measurements
Merge Healthcare is recalling specific versions of Merge PACS software because lesion measurements differ between unmagnified and magnified mammography 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: The recall involves a medical device software defect that affects the accuracy of diagnostic measurements, posing a risk of harm through potential misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Merge Healthcare, Inc. is recalling specific versions of Merge PACS software. The software is intended to create and display two-dimensional and three-dimensional images of anatomy from digitally acquired images. The affected software versions are 6.0.2.0 MR2, 6.0.3.0 MR3, and 6.0.3.1 MR3 CU1.
The recall is due to a defect where measurements of a lesion taken on an unmagnified mammography image do not match measurements taken on the same lesion when the image is magnified by the Hologic imager. This inconsistency in measurement accuracy affects the reliability of the software's diagnostic display capabilities.
The affected software was distributed worldwide, specifically in the USA and Australia. Approximately 49 sites potentially have the affected versions. Users of this software should contact Merge Healthcare for further instructions on how to address the measurement discrepancy.
The recalled product
- Product
- Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 49
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 versions 6.0.2.0 MR2
- 6.0.3.0 MR3
- 6.0.3.1 MR3 CU1
Distribution
Distribution scope not specified by the agency.
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