Home / Recalls / Xcision Medical Systems, LLC / Z-0750-2024

Z-0750-2024 Class II Ongoing

Recalled by Xcision Medical Systems, LLC — Columbia, MD

Recall Details

Product Type: Devices
Report Date: January 24, 2024
Initiation Date: November 30, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4 units

Product Description

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.

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 Pattern

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

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)