GammaPod Radiation Treatment Planning System Software Error Allows Wrong Imaging Structures
Xcision Medical Systems recalled 4 GammaPod Treatment Planning Systems due to a software error that allows incorrect radiation structures from previous CT scans to be imported and selected, potentially affecting treatment planning accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a software defect that creates risk of treatment planning error in radiation therapy. No illnesses or injuries have been reported, so per the severity rubric this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The GammaPod Treatment Planning System is a medical device component used to plan stereotactic radiation therapy for partial breast treatment. Xcision Medical Systems recalled 4 units of this system due to a software error that allows radiation structures (anatomical references) generated from previous CT scans to be incorrectly imported and selected in the treatment planning process.
This defect could result in the use of wrong anatomical structure references during radiation treatment planning, potentially leading to inaccurate radiation dose delivery. No illnesses or injuries have been reported.
The recall affects units distributed in Maryland, Pennsylvania, Texas, and Italy. Healthcare providers using affected units should contact Xcision Medical Systems for instructions on device correction or replacement.
The recalled product
- Product
- GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 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.
- Manufacturer
- Xcision Medical Systems, LLC
- Affected units
- 4
Distribution
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