FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge RadSuite software. Radiological image processing system.
- Recall number
- Z-2715-2016
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge RadSuite software. Radiological image processing system.
- Status
- Terminated
- Initiated
- 2015-04-09
- Posted
- 2016-09-02
- Terminated
- 2017-08-24
- Reason
- When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient.
- Root cause
- Software design
- Action
- The recalling firm issued letters dated 4/3/2015 via email on 4/9/2015 notifying the customer of the issues.
- Quantity
- 10 sites have the affected software that is configured with the specific conditions listed in Code Information
- Distribution
- Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX.
- Lot, serial or model codes
- RadSuite Versions: 5.30.8, 5.35.3, 5.35.4, 5.35.5, 8.30.7.3, 8.30.7.4, 8.30.7.5, 8.30.7.7 are affected, BUT ONLY if they are configured with all of the following conditions: (1) Must have IPID enabled; (2) Must use IPID morphers (3) Must Define a Defaultvalue in the IPID Morpher; (4) Must use the Aggregating Morpher; (5) Must not set OverwritelfPresent=false; and (6) Must be on an internal store (this is data that is already present on EA being stored to Radsuite, this excludes direct DICOM stores to the EA).
- 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