Recall Z-0750-2024— Xcision Medical Systems, LLC

Name: FDA recall Z-0750-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-30

Class II · Ongoing

Class II FDA medical device recall by Xcision Medical Systems, LLC, initiated 2023-11-30. It names 2 FDA 510(k) clearances: K180571, K172706. 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.. Reason: Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected.

Recalling firm: Xcision Medical Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-11-30
Firm location: Columbia, MD, United States

510(k) clearances named in this recall

2 on FDA's record

K180571 — GammaPodXcision Medical Systems, LLC·cleared 2018-04-04
K172706 — GammaPod - Model AXcision Medical Systems, LLC·cleared 2017-12-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.