FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge OrthoPACS software.
- Recall number
- Z-2620-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge OrthoPACS software.
- Status
- Terminated
- Initiated
- 2017-05-24
- Posted
- not on file
- Terminated
- 2019-06-28
- Reason
- A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
- Root cause
- Software design
- Action
- The recalling firm issued a letter dated 5/19/2017 via email on 5/24/2017 or via certified mail if they did not have an email address for the customer.
- Quantity
- 98 sites potentially have the affected versions
- Distribution
- Distribution was made nationwide to medical facilities. There was no foreign/government/military distribution.
- Lot, serial or model codes
- Versions 6.6, 6.6.1, and 6.6.2
- 510(k) numbers
- not on file
- 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