Merge PACS software recalled due to patient name mismatch
Merge Healthcare is recalling PACS software versions V6.0.2.0 MR2 and earlier because patient names in the interface do not match the displayed 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 medical device software defect that poses a risk of harm through patient misidentification, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge PACS software, versions V6.0.2.0 MR2 and earlier. The software was distributed under the AMICAS label in Brighton, MA, before the labeling was changed to Merge Healthcare in Hartland, WI.
The recall is due to a software defect where the patient name displayed in the Halo title bar and thumbnails does not match the name on the displayed images. This discrepancy could lead to confusion regarding patient identity during image review.
The affected software was distributed to medical facilities nationwide, with government distribution to Minnesota and foreign distribution to Australia and the United Kingdom. There was no military distribution. A total of 93 sites have the affected version. Consumers and medical facilities should contact Merge Healthcare for further instructions on resolving this issue.
The recalled product
- Product
- Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — PACS Software
- Affected units
- 93
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)
- Versions: V6.0.2.0 MR2 and earlier
Distribution
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