FDA Recall
Open, Classified
X80 RADiant Photoelectric Therapy System
Recall: Z-1404-2022
·
Initiated April 27, 2022
Recall
- Recall Number
- Z-1404-2022
- Event Number
- 90231
- Firm
- Xstrahl Limited
- FEI Number
- 3004561814
- Product Code
- JAD
- Status
- Open, Classified
- Root Cause
- Finished device change control
- Initiated
- April 27, 2022
- Address
- Maybrook Industrial Estate Maybro; Maybrook Road Walsall United Kingdom Unit 2
Description
X80 RADiant Photoelectric Therapy System
Reason
There is a potential compatibility issue with the systems and replacement treatment applicators.
Action
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.
Distribution
US Distribution FL, CA, KY
Quantity
7 devices; 70 treatment applicators