Home / Recalls / Xcision Medical Systems, LLC / Z-2081-2019

Z-2081-2019 Class II Terminated

Recalled by Xcision Medical Systems, LLC — Columbia, MD

Recall Details

Product Type: Devices
Report Date: July 31, 2019
Initiation Date: July 3, 2019
Termination Date: July 1, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2

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.

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.

Distribution Pattern

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

Code Information

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