Z-1404-2022 Class II Ongoing
FDA device recall Z-1404-2022 was initiated by Xstrahl Limited on April 27, 2022 and is designated Class II. Reason for recall: There is a potential compatibility issue with the systems and replacement treatment applicators. The recall status is ongoing. Affected quantity: 7 devices; 70 treatment applicators.
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2022
- Initiation Date
- April 27, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 devices; 70 treatment applicators
Product Description
X80 RADiant Photoelectric Therapy System
Reason for Recall
There is a potential compatibility issue with the systems and replacement treatment applicators.
Distribution Pattern
US Distribution FL, CA, KY
Code Information
Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008