Merge PACS software recall for horizontal image cut lines
Merge Healthcare is recalling Merge PACS software because image cut lines may appear horizontally instead of vertically.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a display orientation issue (horizontal vs. vertical cut lines) without reported injuries or illnesses, fitting the criteria for a moderate severity software defect.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge PACS (Picture Archiving Communication System) software. The software is designed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography.
The recall is due to a defect where cut lines on the image may present horizontally rather than vertically. This issue affects specific versions of the software, including V6 GA through 7.0.2.
Approximately 537 sites potentially have the affected versions. The product was distributed nationwide in the US, in Canada, and in foreign countries. Users should contact Merge Healthcare for further instructions on how to address the issue.
The recalled product
- Product
- Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 537
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 (20)
- Versions V6 GA
- 6.0 MR1
- V6 MR1 CU1
- V6 MR1 CU1 SF1
- V6 MR1 CU4
- V6 MR1 CU5
- V6 MR1 CU6
- V6 MR1 CU7
- V6 MR1 CU8
- 6.0 MR2
- 6.0 MR3
- 6.0 MR3 CU
- 6.0 MR4
- 6.0 MR4 CU1
- 6.0 MR4 CU2
- 6.0 MR4 CU3
- 6.0 MR4 CU4
- 6.0 MR4 CU5
- 6.0 MR4 CU6
- CU7
Distribution
Distributed nationwide across the United States.
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