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)
This recall is currently active, issued March 25, 2021. It was issued by Raysearch Laboratories Ab Sveavagen 9 Stockholm Sweden.
- Recall Initiated
- March 25, 2021
- Recall Number
- Z-1427-2021
- Quantity
- 1 system
- Official Source
- View on FDA website ↗
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.
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