Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering,

FDA device recall Z-2628-2017 · posted 2017-05-25 · Terminated

Recall details

Recalling firm

Merge Healthcare, Inc.

Reason for recall

There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified.

Action taken

Merge Healthcare issued a letter dated April 15, 2017, via email or via certified mail if they did not have an email address for the customer. The letter notifies the customer of the issue, informs them of a workaround, and lets them know a fix is being planned and they will be notified once it is made 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 29, 2016. For further questions, call (877) 741-5369.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

638 sites have the potentially affected versions

Distribution

Nationwide Distribution to facilities and distributors. Distribution was made to the Virgin Islands. Foreign distribution was also made. There was no military/government distribution.

Date initiated

2016-04-15

Date posted

2017-05-25

Date terminated

2019-03-13

Location

Hartland, WI