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Recall Observatory FDA recall evidence

Device 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.

Z-0750-2024

November 30, 2023

Class II

Product summary

Firm
Xcision Medical Systems, LLC
Event
Event 93684
Status
Ongoing
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-0750-2024

Official wording

Reason: Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected

Code information: 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)

Distribution pattern: Worldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected