DR Systems Unity PACS software, now known as Merge Unity PACS
Recall
- Recall Number
- Z-1426-2017
- Event Number
- 76541
- Firm
- Merge Healthcare, Inc.
- FEI Number
- 1000116130
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- April 8, 2016
- Posted
- March 9, 2017
- Terminated
- March 17, 2017
- Address
- 900 Walnut Ridge Dr, Hartland, WI, 53029-8347
Description
DR Systems Unity PACS software, now known as Merge Unity PACS
Reports were missing demographic header information when they were faxed to referring physicians.
Merge sent an Urgent : Medical Device Recall letter dated March 28, 2016, to all affected customers via email on April 8, 2016. Nonresponders were issued a second letter dated July 11, 2016. The letter notifies the customer of the issue, makes them aware of a workaround, and informs them a fix is available. 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 8, 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. For further questions please call ( 877) 741-5369.
US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/military/government distribution.
9 sites potentially have the affected version