FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
- Recall number
- Z-2159-2016
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
- Status
- Terminated
- Initiated
- 2016-01-31
- Posted
- 2016-07-11
- Terminated
- 2017-01-26
- Reason
- Potential data loss occurs as a result of product archiving not working properly.
- Root cause
- Software design
- Action
- The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/31/2016 explaining the reason for recall and instructing the customer to provide a copy of the notification to all users.
- Quantity
- 49 sites have the affected software
- Distribution
- Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/military/foreign distribution.
- Lot, serial or model codes
- Version 3.4
- 510(k) numbers
- K033825
- 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