GammaPod Stereotactic Radiotherapy System Recalled for Alignment Drift
Xcision Medical Systems is recalling two GammaPod Stereotactic Radiotherapy Systems because a loose bolt caused alignment drift and reduced radiation dose output.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). The mechanical defect causing reduced therapeutic dose output represents a significant functional failure of a medical device.
Plain-English summary
Xcision Medical Systems, LLC is recalling two units of the GammaPod Stereotactic Radiotherapy System Model A (REF XMSGP030A00-0.02). The recall involves serial numbers GP0002 and GP0004. These devices are teletherapy systems intended for the noninvasive stereotactic delivery of radiation to a partial volume of the breast in conjunction with breast-conserving treatment.
The recall was initiated because one bolt on the V motor was not fully tightened. This mechanical issue caused a drift of .13 degrees in alignment, which resulted in reduced dose output. The affected products were distributed to facilities in Maryland and Texas.
Healthcare facilities that have received these specific units should contact Xcision Medical Systems for instructions on how to address the defect. Patients who have received treatment on these specific serial numbers should consult their healthcare provider regarding the potential impact of the reduced dose output.
The recalled product
- 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 treat
- Manufacturer
- Xcision Medical Systems, LLC
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Serial Numbers GP0002
- GP0004
- UDI: (01) 00850002615005
Distribution
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