FDA recall Z-1597-2020

Elekta Impac Software · Class II · device

Product

MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.

Reason for recall

The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.

Distribution

Worldwide distribution.

Key facts

Status
Ongoing
Initiation date
2019-09-24
Report date
2020-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1597-2020