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Merge Cardio software with Issuer of Patient ID (IPID).… recallZ-1496-2017 · Merge Healthcare, Inc. · initiated Sep 22, 2015

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

For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common.

FDA root cause category: Process design

What the company is doing

Merge sent an Urgent: Medical Device Recall letter dated March 28, 2016, via email the week of April 4, 2016, or via certified mail if they did not have an email address for the customer. On/about September 22, 2015, the recalling firm emailed "IMPORTANT PRODUCT INFORMATION" letters dated August 20, 2015, to their customers. The letter notifies the customer of the issue and informs them a fix for the issue is in the new software release. 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. 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. .

Recall details

Recall number
Z-1496-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 22, 2015
Posted by the FDA
Mar 20, 2017
Recalling firm
Merge Healthcare, Inc.
Quantity
16 sites were originally identified as potentially having the affected versions
Product code
LLZ
FDA submissions
K051649
Distribution
US Distribution was made to medical facilities located in GA, IL, MD, MI, MO, OH, TN, and VT. There was no foreign/government/military distribution.

Product description

Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.

Code information (models, lots, serial numbers)

Versions 8.30, 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 10.0, 10.0.1, and 10.1 with Issuer of Patient ID (IPID)

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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