Device product
GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
Z-2081-2019
Product summary
- Event
- Event 83342
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-2081-2019
Official wording
Reason: One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
Code information: Serial Numbers GP0002, GP0004; UDI: (01) 00850002615005
Distribution pattern: The products were distributed to the following US states: MD and TX.
Derived failure modes
-
Unknown
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.