Merge PACS software. Product Usage: Merge PACS recall: Software Issue
Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication…
Why was Merge PACS software. Product Usage: Merge PACS recalled?
The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Versions: V6.0 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, 6.0 MR4, CU7, 6.0 MR4 CU8, 6.0 MR4 CU9, 6.0 MR4 CU10, 6.0 MR4 CU11, 6.1, 6.1.1, 6.1.2, 6.1.3, 6.2, 6.2.1, 6.2.2, 6.2.3, 6.2.4, 6.2.5, 6.3, 6.4, 6.4.1, 6.4.2, 6.4.3, 6.4.4, 6.4.5, 6.4.6, 6.4.7, 6.5, 6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6, 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1, and 7.0.2.
- Product
- Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication…
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 534 sites potentially have the affected versions
- Distribution
- Worldwide Distribution - US Nationwide including Canada.
- Recall date
- November 23, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)