Reported Jul 31, 2019 · Terminated
GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device…
Xcision Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Xcision Medical Systems, LLC · 9176 Red Branch Rd · Columbia, MD · 21045-2001
Is this the product you have?
- GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02
- Product UsageGammaPod 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
- Lot codes and dates
Serial Numbers GP0002GP0004
- UDI(01) 00850002615005
- Amount recalled
- 2
Where it was sold
Why it was recalled
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
This product could cause temporary or reversible health problems — stop using it.
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