Recall Z-1404-2022 ยท JAD System, Therapeutic, X-Ray
Xstrahl Limited
X80 RADiant Photoelectric Therapy System
| Date | Apr 27, 2022 |
| Status | Open, Classified |
| Reason | There is a potential compatibility issue with the systems and replacement treatment applicators. |
| Root cause | Finished device change control |
| 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. |
| Quantity | 7 devices; 70 treatment applicators |
| Distribution | US Distribution FL, CA, KY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172080 | Photoelectric Therapy System Xstrahl, Ltd., Sep 29, 2017 |