FDA recall Z-1299-2022

Product

RayStation 11B

Reason for recall

This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.

Distribution

US Nationwide distribution in the states of NJ and TX.

Key facts

Status

Terminated

Initiation date

2022-06-10

Report date

2022-07-06

Termination date

2024-06-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stockholm, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1299-2022