Columbia, MD, United States
Xcision Medical Systems, LLC recalls
2 recalls recorded since 2018, most recently on 30 November 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 30 November 2023
- Reason
- Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
- Distribution
- Worldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0750-2024
- GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the
Terminated Class II Medical devices
- Recall started
- 3 July 2019
- Terminated
- 1 July 2021
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2081-2019
- 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 volu
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.