FDA recall Z-2620-2017

Merge Healthcare, Inc. · Class II · device

Product

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.

Distribution

Distribution was made nationwide to medical facilities. There was no foreign/government/military distribution.

Key facts

Status
Terminated
Initiation date
2017-05-24
Report date
2017-06-28
Termination date
2019-06-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hartland, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2620-2017