RAYSEARCH LABORATORIES AB: Medical Device Recall in 2022 - (Recall #: Z-1299-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

RayStation 11B

Product Classification:

Class II

Date Initiated: June 10, 2022

Date Posted: July 6, 2022

Recall Number: Z-1299-2022

Event ID: 90505

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.

Status: Terminated

Product Quantity: 26

Code Information:

UDI-DI 0735000201042620211208 Software version numbers 12.0.0.932, 12.1.0.1221, 12.0.3.68

Distribution Pattern:

US Nationwide distribution in the states of NJ and TX.

Voluntary or Mandated:

Voluntary: Firm initiated