FDA recall Z-1404-2022
Xstrahl Limited · Class II · device
Product
X80 RADiant Photoelectric Therapy System
Reason for recall
There is a potential compatibility issue with the systems and replacement treatment applicators.
Distribution
US Distribution FL, CA, KY
Key facts
- Status
- Ongoing
- Initiation date
- 2022-04-27
- Report date
- 2022-07-27
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Walsall, N/A, United Kingdom
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1404-2022