FDA recall Z-2081-2019

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.

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

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

Key facts

Status

Terminated

Initiation date

2019-07-03

Report date

2019-07-31

Termination date

2021-07-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbia, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2081-2019