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.
This recall has been terminated (originally issued July 3, 2019).
- Company
- Xcision Medical Systems, Llc
- Recall Initiated
- July 3, 2019
- Terminated
- July 1, 2021
- Recall Number
- Z-2081-2019
- Quantity
- 2
- Firm Location
- Columbia, MD
- Official Source
- View on FDA website ↗
Reason for Recall
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
Distribution
The products were distributed to the following US states: MD and TX.
Lot / Code Info
Serial Numbers GP0002, GP0004; UDI: (01) 00850002615005
Root Cause
Nonconforming Material/Component
Action Taken
The firm sent a Field Correction Notice letters dated 7/3/19 to customers. The letter identified the affected product, problem and actions to be taken. If you need any further information or support concerning this issue, please contact Xcsion Customer Support at 855-924-7466.