Z-0750-2024Class II

GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01...

Name: Z-0750-2024 GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01...
Creator: Xcision Medical Systems, LLC
Published: 2023-11-30
License: https://open.fda.gov/license/

Xcision Medical Systems, LLC / initiated 2023-11-30 / Open, Classified / root cause: software

FDA source

Xcision Medical Systems, LLC began a recall of GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic... on 2023-11-30. FDA classified it as Class II and gives the reason as "Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0750-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-30
Posted: 2024-01-18
Recalling firm: Xcision Medical Systems, LLC
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.
Product code: IWB System, Radiation Therapy, Radionuclide
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
Root cause tag: software
FDA root cause: Software design
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).
Quantity in commerce: 4 units
Distribution: Worldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0750-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0750-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-18

Product code IWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)