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Open, Classified

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.

FDA Recall Z-0750-2024 · Posted 2024-01-18

Recalling FirmXcision Medical Systems, LLC
Recall StatusOpen, Classified
Product CodeIWB
Date Initiated2023-11-30
Product Quantity4 units

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

Firm Action

Xcision issued Urgent Field Correction Letter via email on 11/30/23. Letter states reason for recall, health risk and action to take: Please post this notification internally for awareness of GammaPod BY CUSTOMER/USER Treatment Planning System users. Xcision is working on an update to the TPS software to implement controls to identify not only the patient identification but also the series of which the structures were delineated. This change is expected for implementation in early 2024. If you need any further information or support concerning this issue, please contact Xcision Customer Support at 855-924-7466 (1-855- SUPPORT XCISION).

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K180571GammaPodXcision Medical Systems, LLC · 2018-04-04K172706GammaPod - Model AXcision Medical Systems, LLC · 2017-12-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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