FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Recall number
- Z-2590-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Status
- Terminated
- Initiated
- 2017-05-08
- Posted
- not on file
- Terminated
- 2019-08-05
- Reason
- Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.
- Root cause
- Software design (manufacturing process)
- Action
- Merge Healthcare sent an Urgent Medical Device Recall letter dated May 5, 2017. The letter explains the issue and informs the customer to be aware of the workaround. The customer is also notified a software fix for the issue was released in Merge PACS 7.1.1 (or later). The customer is requested to ensure all users of the product are provided with the notification and if it has been further distributed, to notify downstream customers at once. The letter informs the customer a response is required 15 calendar days after receipt of the recall letter. The enclosed response asks, in part, if the customer is interested in accepting the fix and if not, to state the reason why. The recalling firm will contact all unresponsive customers a second and third time. Methods for contacting the customer may be by phone or email. For further questions, please call (877) 741-5369.
- Quantity
- 47 sites potentially have the affected versions
- Distribution
- USA (nationwide) Distribution .There was no foreign/government/military distribution.
- Lot, serial or model codes
- Versions 7.0.2.1, 7.0.2.2, 7.0.2.3, 7.0.2.3 P1, and 7.0.2.3 P2
- 510(k) numbers
- ["K082144"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1000116130
- Firm city
- Hartland
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28