FDAFDA · Food and drugs·Recall number Z-0750-2024
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.
Published January 24, 2024 · Recall initiated: November 30, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Xcision Medical Systems, LLC
- Distributor
- Worldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy.
- Lot
- 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)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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