FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Fusion Workstation.; Indicated for the transmission and review of radiological images.
- Recall number
- Z-0294-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Fusion Workstation.; Indicated for the transmission and review of radiological images.
- Status
- Terminated
- Initiated
- 2011-10-28
- Posted
- not on file
- Terminated
- 2016-12-14
- Reason
- After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.
- Root cause
- Software design
- Action
- The recalling firm initiated phone calls to affected sites beginning 1/30/2016.
- Quantity
- 13 sites potentially hae the affected version
- Distribution
- Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ.
- Lot, serial or model codes
- Versions V3.0.2 P3, 3.02, 3.1, 3.2, 3.3, and 3.3.1.
- 510(k) numbers
- ["K983401"]
- 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