FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Recall number
- Z-2601-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Status
- Terminated
- Initiated
- 2017-05-24
- Posted
- not on file
- Terminated
- 2019-10-15
- Reason
- Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
- Root cause
- Software design (manufacturing process)
- Action
- Merge Healtcare sent an Urgent Medical Device Recall letter dated May 19, 2017, via email on May 24, 2017. The letter notifies the customer of the issue, informs them to be aware of the workaround, and that a fix is available for the issue in Merge OrthoPACS 6.6.3.2 (or later). The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required 15 calendar days after receipt of the recall letter using the enclosed form. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The recalling firm will contact all unresponsive customers with a second customer letter, followed by a third customer letter. They may additionally contact customers that are unresponsive via telephone. For further questions, please call ( 877) 741-5369.
- Quantity
- 160 sites potentially have the affected versions
- Distribution
- USA (nationwide) Distribution was made to medical facilities. There was no foreign/government/military distribution.
- Lot, serial or model codes
- Versions 6.6, 6.6.1, 6.6.2, 6.6.2.1, and 6.6.2.2
- 510(k) numbers
- ["K022881","K082144","K092915"]
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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