Reported Jan 24, 2024 · Ongoing
GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended…
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 Ste O · Columbia, MD · 21045-2001
Is this the product you have?
- GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System
- RefXMSGP030A09.07-0.01 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
- Lot codes and dates
- 00850002615029(11)230321(21)TPS0018 (Distributed in the US) 00850002615029(11)230629(21)TPS0013 (Distributed in the US) 00850002615005(11)21H24(21)TPS0016 (Distributed in the US) 00850002615029(11)210629(21 )TPS0014 (Italy)
- Amount recalled
- 4 units
Where it was sold
Why it was recalled
Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
This product could cause temporary or reversible health problems — stop using it.
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