Recall Z-1496-2017— Merge Healthcare, Inc.

Name: FDA recall Z-1496-2017
Creator: U.S. Food and Drug Administration
Published: 2015-09-22

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2015-09-22, terminated 2017-04-18. It names one FDA 510(k) clearance: K051649. Product: Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.. Reason: For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-09-22
Terminated: 2017-04-18
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 software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.

Reason for recall

For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common.

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