Xcision Medical Systems, LLC: Medical Device Recall in 2019 - (Recall #: Z-2081-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: July 3, 2019

Date Posted: July 31, 2019

Recall Number: Z-2081-2019

Event ID: 83342

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.

Status: Terminated

Product Quantity: 2

Code Information:

Serial Numbers GP0002, GP0004; UDI: (01) 00850002615005

Distribution Pattern:

The products were distributed to the following US states: MD and TX.

Voluntary or Mandated:

Voluntary: Firm initiated