Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

GammaPod Stereotactic Radiotherapy System Model A Recalled by Xcision Medical Systems, LLC Due to One bolt on the V motor was not...

Date: July 3, 2019
Company: Xcision Medical Systems, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Xcision Medical Systems, LLC directly.

Affected Products

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.

Quantity: 2

Why Was This Recalled?

One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.

Where Was This Sold?

This product was distributed to 2 states: MD, TX

Affected (2 states)Not affected

About Xcision Medical Systems, LLC

Xcision Medical Systems, LLC has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report