FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
- Recall number
- Z-2709-2016
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
- Status
- Terminated
- Initiated
- 2016-02-09
- Posted
- 2016-09-01
- Terminated
- 2017-08-24
- Reason
- A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).
- Root cause
- Software design
- Action
- MERGE sent an Urgent Medical Device Recall letter dated February 9, 2016, to all affected customers via email or via certified mail if they did not have an e-mail address for the customer. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it. For further questions, please call (800) 724-5970 ext. 8027.
- Quantity
- 116 customers potentially have the affected versions
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Versions 10.1 and 10.1.1
- 510(k) numbers
- ["K051649"]
- 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