Z-1427-2021 Class II Ongoing
FDA device recall Z-1427-2021 was initiated by RAYSEARCH LABORATORIES AB on March 25, 2021 and is designated Class II. Reason for recall: Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat. The recall status is ongoing. Affected quantity: 1 system.
Recall Details
- Product Type
- Devices
- Report Date
- April 21, 2021
- Initiation Date
- March 25, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 system
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)
Reason for Recall
Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
Distribution Pattern
US Nationwide in the state of TN.
Code Information
Software version: 9A, 9B, 10A, 10B