FDA Recall Terminated

Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

Recall: Z-0729-2017 · Initiated March 28, 2016

Recall

Recall Number: Z-0729-2017
Event Number: 75825
Firm: Merge Healthcare, Inc.
FEI Number: 1000116130
Product Code: LLZ
Status: Terminated
Root Cause: Software design
Initiated: March 28, 2016
Terminated: March 20, 2020
Address: 900 Walnut Ridge Dr, Hartland, WI, 53029-8347

Description

Reason

If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still associated to the correct patient).

Action

MERE sent an Urgent Medical Device Recall letter dated July 11, 2016, to all affected customers via email or via certified mail if they did not have an email address for the customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to respond to the notification using the enclosed form and the return addressed envelope. Customers were also instructed to ensure that all users of the product are provided with the notification and if product was further distributed customers need to identify their customers and notify them at once of the product recall. Customers with questions should send an email to [email protected]. For questions regarding this recall call 877-741-5369.

Distribution

Nationwide Distribution

Quantity

198 sites potentially have the effected versions