FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
- Recall number
- Z-1415-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
- Status
- Terminated
- Initiated
- 2016-04-04
- Posted
- 2017-03-08
- Terminated
- 2017-03-20
- Reason
- A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.
- Root cause
- Software design
- Action
- Merge sent an Urgent: Medical Device Recall letter dated March 28, 2016, via e-mail on April 4, 2016. A letter was issued to nonresponders on July 11, 2016. The letter notifies the customer of the issue, informs them of the workaround, and that no further action was being taken to correct the issue, therefore, the customer needs to be aware of the possible behavior. 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 understand the workaround. The response was required no later than April 18, 2016. Nonresponders were issued a second letter dated July 11, 2016, asking for a response by August 2, 2016. The letter and response form contained the same information as the first letter. If the second letter results in additional unresponsive customers, a call campaign will be managed by Customer Support and documented via SalesForce. Three call attempts will made before closing the case. For further information please call (877) 741-5369.
- Quantity
- 17 sites potentially have the affected versions
- Distribution
- US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.
- Lot, serial or model codes
- Version 9.0.9 and earlier using EchoIMS.
- 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