PlainRecalls
FDA Devices Moderate Class II Terminated

Merge OrthoPACS software.

Reported: June 28, 2017 Initiated: May 24, 2017 #Z-2620-2017

Product Description

Merge OrthoPACS software.

Reason for Recall

A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.

Details

Recalling Firm
Merge Healthcare, Inc.
Units Affected
98 sites potentially have the affected versions
Distribution
Distribution was made nationwide to medical facilities. There was no foreign/government/military distribution.
Location
Hartland, WI

Frequently Asked Questions

What product was recalled?
Merge OrthoPACS software.. Recalled by Merge Healthcare, Inc.. Units affected: 98 sites potentially have the affected versions.
Why was this product recalled?
A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 28, 2017. Severity: Moderate. Recall number: Z-2620-2017.