FDA recall Z-1466-2022

Product

Centricity PACS Software Version 7.0 SP0.0.4.7

Reason for recall

The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.

Distribution

Worldwide distribution - US Nationwide distribution in the states of CO, NV, OH, PA, WA and the countries of Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Oman, Spain, Switzerland, and United Kingdom.

Key facts

Status

Terminated

Initiation date

2022-06-14

Report date

2022-08-03

Termination date

2024-01-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1466-2022