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DR Systems Unity PACS software, now known as Merge Unity… recallZ-1426-2017 · Merge Healthcare, Inc. · initiated Apr 8, 2016

Class II Terminated All recalls posted in March 2017

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Merge Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-1426-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 8, 2016
Posted by the FDA
Mar 9, 2017
Recalling firm
Merge Healthcare, Inc.
Quantity
9 sites potentially have the affected version
Product code
LLZ
FDA submissions
K041935
Distribution
US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/military/government distribution.

Product description

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

Code information (models, lots, serial numbers)

Version 11.0

Other devices under the same FDA submission

4 devices cleared under K041935 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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