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
FDA Recall Z-0730-2017 · Posted None
Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2015-10-01
Date Terminated2018-03-23
Product Quantity116 sites potentially have the effected versions
Reason for Recall
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution
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.