Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.
FDA Recall Z-2123-2017 · Posted 2017-05-22
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Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-04-13
Date Terminated2017-07-17
Product Quantity30 sites have the potentially affected software versions
Reason for Recall
Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced.
Firm Action
The recalling firm issued a "Medical Device Correction" letter dated 4/13/2016 via e-mail. The letter identified the affected product, issue involved, potential harm, a work around, as well as the actions to be performed by both the customer and firm. Merge Technical Support will contact customers to discuss the fix. Customers are to ensure that all users are provided the notice. If the affected product was further distributed, those customers should be identified and notified of the issue. A copy of the notice may be provided to those customers. If there are additional questions, customers can e-mail [email protected].
Root Cause
Software design
Distribution Pattern
Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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