PlainRecalls
FDA Devices Moderate Class II Terminated

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.

Reported: September 7, 2016 Initiated: February 9, 2016 #Z-2709-2016

Product Description

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.

Reason for Recall

A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).

Details

Recalling Firm
Merge Healthcare, Inc.
Units Affected
116 customers potentially have the affected versions
Distribution
Nationwide Distribution
Location
Hartland, WI

Frequently Asked Questions

What product was recalled?
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.. Recalled by Merge Healthcare, Inc.. Units affected: 116 customers potentially have the affected versions.
Why was this product recalled?
A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).
Which agency issued this recall?
This recall was issued by the FDA Devices on September 7, 2016. Severity: Moderate. Recall number: Z-2709-2016.