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Merge Cardio software using EchoIMS. The firm name on the… recallZ-1415-2017 · Merge Healthcare, Inc. · initiated Apr 4, 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

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.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-1415-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 4, 2016
Posted by the FDA
Mar 8, 2017
Recalling firm
Merge Healthcare, Inc.
Quantity
17 sites potentially have the affected versions
Product code
LLZ
FDA submissions
K051649
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.

Product description

Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

Code information (models, lots, serial numbers)

Version 9.0.9 and earlier using EchoIMS.

Other devices under the same FDA submission

4 devices cleared under K051649 — 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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