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-1176-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Status
- Terminated
- Initiated
- 2016-04-04
- Posted
- not on file
- Terminated
- 2019-04-08
- Reason
- Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.
- Root cause
- Software design
- Action
- The recalling firm issued a letter dated 3/28/2016 via email on 4/4/2016 or via certified mail if they did not have an email address for the customer. A second letter was issued 7/11/2016 to nonresponders.
- Quantity
- 29 sites have the potentially affected software
- Distribution
- Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military distribution.
- Lot, serial or model codes
- Version 7.0.1
- 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
- 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