FDA recall Z-1427-2021

Product

RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)

Reason for recall

Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.

Distribution

US Nationwide in the state of TN.

Key facts

Status

Ongoing

Initiation date

2021-03-25

Report date

2021-04-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stockholm, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1427-2021