RecallDepth

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)

Company
Raysearch Laboratories Ab Sveavagen 9 Stockholm Sweden
Recall Initiated
March 25, 2021
Recall Number
Z-1427-2021
Quantity
1 system

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.

Lot / Code Info

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

Root Cause

Under Investigation by firm

Action Taken

On 03/25/2021, RaySearch Laboratories issued an Urgent Medical Device Correction notice via email to their customer notifying them of an issue found with the display of flags in RayTreat. Flags edited in RayCare after a patient has been checked in, may not be updated in RayTreat.

More recalls by Raysearch Laboratories Ab Sveavagen 9 Stockholm Sweden

View all recalls by this company →