Z-2081-2019Class II

GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02

Name: Z-2081-2019 GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02
Creator: Xcision Medical Systems, LLC
Published: 2019-07-03
License: https://open.fda.gov/license/

Xcision Medical Systems, LLC / initiated 2019-07-03 / Terminated / root cause: manufacturing process

FDA source

Xcision Medical Systems, LLC began a recall of GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in the noninvasive... on 2019-07-03. FDA classified it as Class II and gives the reason as "One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2081-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-03
Posted: 2019-07-25
Terminated: 2021-07-01
Recalling firm: Xcision Medical Systems, LLC
Product: GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device 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: One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm sent a Field Correction Notice letters dated 7/3/19 to customers. The letter identified the affected product, problem and actions to be taken. If you need any further information or support concerning this issue, please contact Xcsion Customer Support at 855-924-7466.
Quantity in commerce: 2
Distribution: The products were distributed to the following US states: MD and TX.
Product codes and lots: Serial Numbers GP0002, GP0004; UDI: (01) 00850002615005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2081-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2081-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-25

Product code IWB

K180571Class IIGammaPodXcision Medical Systems, LLC / cleared 2018-04-04

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)