Z-1468-2020 Class II Terminated
FDA device recall Z-1468-2020 was initiated by RAYSEARCH LABORATORIES AB on February 20, 2020 and is designated Class II. Reason for recall: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or ro… The recall status is terminated (terminated November 5, 2024). Affected quantity: 1 system in the U.S..
Recall Details
- Product Type
- Devices
- Report Date
- March 18, 2020
- Initiation Date
- February 20, 2020
- Termination Date
- November 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 system in the U.S.
Product Description
RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
Reason for Recall
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
Distribution Pattern
The products were distributed to the following US states: TN
Code Information
UDI 07350002010266