Recall Z-0555-2016— Merge Healthcare, Inc.

Name: FDA recall Z-0555-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-26

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2015-10-26, terminated 2016-07-22. It names one FDA 510(k) clearance: K051649. Product: Merge Cardio with software version 10.1 LA.. Reason: The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-10-26
Terminated: 2016-07-22
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K051649 — VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0Camtronics Medical Systems·cleared 2005-08-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Merge Cardio with software version 10.1 LA.

Reason for recall

The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.

Data sourced from openFDA. This site is unofficial and independent of the FDA.