DR Systems Unity PACS software, now known as Merge Unity PACS

FDA device recall Z-1426-2017 · posted 2017-03-09 · Terminated

Recall details

Recalling firm

Merge Healthcare, Inc.

Reason for recall

Reports were missing demographic header information when they were faxed to referring physicians.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

9 sites potentially have the affected version

Distribution

US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/military/government distribution.

Date initiated

2016-04-08

Date posted

2017-03-09

Date terminated

2017-03-17

Location

Hartland, WI

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