FDAFDA · Food and drugs·Recall number Z-2081-2019
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.
Published July 31, 2019 · Recall initiated: July 3, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Xcision Medical Systems, LLC
- Distributor
- The products were distributed to the following US states: MD and TX.
- Lot
- Serial Numbers GP0002, GP0004; UDI: (01) 00850002615005
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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