Xcision Medical Systems recalls GammaPod Stereotactic Radiotherapy System Model A (serials GP0002, GP0004) due to alignment drift causing reduced radiation dose output. Affected users should contact for remedy.
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
Xcision Medical Systems recalls GammaPod Stereotactic Radiotherapy System Model A (serials GP0002 and GP0004) because a bolt wasn't fully tightened, causing the device to drift in alignment and deliver less radiation dose than intended. This could affect the accuracy of breast radiation treatment.
A bolt on the V motor wasn't fully tightened, causing the device to drift by 0.13 degrees in alignment. This results in reduced radiation dose output, potentially affecting the accuracy of breast radiation treatment.
Patients receiving breast cancer treatment using the GammaPod system with serial numbers GP0002 or GP0004 are most at risk. Healthcare providers using this specific model for stereotactic radiotherapy may also be affected.
Check for serial numbers GP0002 or GP0004 on the GammaPod Stereotactic Radiotherapy System Model A. The product is a teletherapy device used for breast radiation treatment.
Reach out to Xcision Medical Systems for instructions on how to address the alignment issue.
GammaPod Stereotactic Radiotherapy System Model A, serial numbers GP0002 and GP0004.
A bolt on the V motor wasn't fully tightened, causing a 0.13-degree alignment drift that reduces radiation dose output.
The recall record does not specify a remedy; users should contact Xcision Medical Systems for instructions.
We’ve drafted a message you can send Xcision Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2081-2019 — Xcision Medical Systems Xcision Medical Systems Hello, I own a Xcision Medical Systems that is covered by recall Z-2081-2019 from Xcision Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.