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

FDA device recall Z-1496-2017 · posted 2017-03-20 · Terminated

Recall details

Recalling firm

Merge Healthcare, Inc.

Reason for recall

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.

Action taken

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. .

Root cause

Process design

Status

Terminated

Product code

LLZ

Quantity affected

16 sites were originally identified as potentially having the affected versions

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.

Date initiated

2015-09-22

Date posted

2017-03-20

Date terminated

2017-04-18

Location

Hartland, WI

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