X80 RADiant Photoelectric Therapy System
- Company
- Xstrahl Limited
- Recall Initiated
- April 27, 2022
- Recall Number
- Z-1404-2022
- Quantity
- 7 devices; 70 treatment applicators
Reason for Recall
There is a potential compatibility issue with the systems and replacement treatment applicators.
Distribution
US Distribution FL, CA, KY
Lot / Code Info
Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008
Root Cause
Finished device change control
Action Taken
The firm sent out the recall notification on 04/27/2022 via email. The letter mentions the consignee is able to continue to use the system. The consignee is to ensure that the verification of selection of the correct applicator for the planned treatment is conducted with the consignee's procedures and radiotherapy professional practice and guidelines. They are asked to complete a response form and return it no later than 30 days.