Xcision Medical Systems, LLC: Medical Device Recall in 2024 - (Recall #: Z-0750-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 30, 2023

Date Posted: January 24, 2024

Recall Number: Z-0750-2024

Event ID: 93684

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

Status: Ongoing

Product Quantity: 4 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated