FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Recall number
- Z-1180-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Status
- Terminated
- Initiated
- 2015-11-17
- Posted
- 2017-02-09
- Terminated
- 2017-02-10
- Reason
- The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
- Root cause
- Software design
- Action
- Merge sent an Urgent Medical Device Recall letter dated March 28, 2016 to all affected customers. The letter notifies the customer of the issue and informs them an upgrade is available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The response was required no later than April 18, 2016. A second letter dated July 11, 2016, was issued asking for a response by August 2, 2016, even though all upgrades were made because the effectiveness checks were not yet completed. The letter and response form contained the same information as the first letter. The recalling firm reported emails were tracked for delivery confirmation and the letters were tracked for delivery by USPS certified services. For further questions, please call 877-744-5369.
- Quantity
- 8 sites have the potentially affected version
- Distribution
- US Distribution was made to medical facilities in AL, IN, MI, PA and WI.
- Lot, serial or model codes
- Version V8.30.7.8
- 510(k) numbers
- K053281
- 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