Recall Z-2081-2019— Xcision Medical Systems, LLC
Class II · Terminated
Class II FDA medical device recall by Xcision Medical Systems, LLC, initiated 2019-07-03, terminated 2021-07-01. It names one FDA 510(k) clearance: K180571. 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: One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output..
- Recalling firm
- Xcision Medical Systems, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-03
- Terminated
- 2021-07-01
- Firm location
- Columbia, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.