FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
- Recall number
- Z-2301-2016
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
- Status
- Terminated
- Initiated
- 2016-01-30
- Posted
- not on file
- Terminated
- 2019-04-08
- Reason
- Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.
- Root cause
- Software design
- Action
- The recalling firm issued Urgent: Medical Device Recall letters dated 1/27/2016 and 5/26/2016. The letter informed the customer of the affected product, the nature of the issue, the potential harm involved, and actions to be taken. The firm released a fix for the issue; and, customers were asked to complete and return the enclosed form by June 17, 2016. Questions can be directed to recall@merge.com.
- Quantity
- 109 sites have the affected versions
- Distribution
- Worldwide Distribution -- USA, New Zealand, and United Kingdom.
- Lot, serial or model codes
- Versions: V6.0 MR4 CU 1-11, 6.1.0, 6.1.1, 6.1.1.1, 6.1.2, 6.1.3, 6.1.3.1, 6.2.0, 6.2.1, 6.2.2, 6.2.2.1, and 6.2.3.
- 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