FDA recall Z-0195-2019

Product

Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.

Reason for recall

Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.

Distribution

NY

Key facts

Status

Terminated

Initiation date

2018-08-30

Report date

2018-10-24

Termination date

2022-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0195-2019