FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Recall number
- Z-1403-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Status
- Terminated
- Initiated
- 2016-04-04
- Posted
- 2017-03-03
- Terminated
- 2019-07-26
- Reason
- When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.
- Root cause
- Software design
- Action
- Merge sent an Urgent : Medical Device Recall letter dated March 28, 2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued a second letter dated July 11, 2016. For further questions, please call (877) 741-5369.
- Quantity
- 110 sites potentially have the affected versions
- Distribution
- Distribution was made to medical facilities nationwide. There was no foreign/military/government distribution.
- Lot, serial or model codes
- Versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 9.0.9, and 10.0.
- 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