Xcision Medical Systems, LLC: 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

Hazard

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

Details from the source

Reason for recall: Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected Distribution: Worldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy. Quantity: 4 units Lot/code info: 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)

UPC codes

00850002615029, 00850002615005

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.