FDA Recall Terminated

Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems 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-0730-2017 · Initiated October 1, 2015

Recall

Recall Number: Z-0730-2017
Event Number: 75714
Firm: Merge Healthcare, Inc.
FEI Number: 1000116130
Product Code: LLZ
Status: Terminated
Root Cause: Software design
Initiated: October 1, 2015
Terminated: March 23, 2018
Address: 900 Walnut Ridge Dr, Hartland, WI, 53029-8347

Description

Reason

Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.

Action

MERGE sent an Urgent Medical Device Recall letter dated March 28, 2016, to all affected customers. Non-responders were issued a second letter dated July 11, 2016, The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to reply using the enclosed form and the return addressed envelope and also to ensure that all users of the product were provided with the notification. If product was further distributed, customer were asked to identify their customers and notify them at once of the product recall. Customers with questions were advised to email [email protected]. For questions regarding this recall call 877-741-5369.

Distribution

Nationwide Distribution

Quantity

116 sites potentially have the effected versions