FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
- Recall number
- Z-1470-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
- Status
- Terminated
- Initiated
- 2016-04-04
- Posted
- 2017-03-10
- Terminated
- 2019-08-28
- Reason
- The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.
- Root cause
- Software design
- Action
- Merge Healthcare sent an Urgent: Medical Device Recall letter dated March 28, 2016, via e-mail the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A second letter dated July 11, 2016, was issued to nonresponders. The letter notifies the customer of the issue and informs them a fix has been released for the issue. 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. 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. The recalling firm reported emails will be tracked for delivery confirmation and the letters will be tracked for delivery by USPS certified services. For further questions, please call (877) 741-5369.
- Quantity
- 187 sites potentially have the affected versions
- Distribution
- USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution.
- Lot, serial or model codes
- iConnect Enterprise Archive versions 5.30.0 thru 9.4.3 and V11.0.
- 510(k) numbers
- ["K053281"]
- PMA numbers
- not on file
- Product code
- LMB
- 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