RAYSEARCH LABORATORIES AB: Medical Device Recall in 2021 - (Recall #: Z-1427-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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)

Product Classification:

Class II

Date Initiated: March 25, 2021

Date Posted: April 21, 2021

Recall Number: Z-1427-2021

Event ID: 87666

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1 system

Code Information:

Software version: 9A, 9B, 10A, 10B

Distribution Pattern:

US Nationwide in the state of TN.

Voluntary or Mandated:

Voluntary: Firm initiated