X80 RADiant Photoelectric Therapy System Compatibility Issue
Xstrahl Limited is recalling specific lot codes of the X80 RADiant Photoelectric Therapy System due to a potential compatibility issue with replacement treatment applicators. Devices were distributed in Florida, California, and Kentucky.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for a potential device compatibility issue with no reported patient injuries or illnesses documented in the source material.
Plain-English summary
Xstrahl Limited is recalling the X80 RADiant Photoelectric Therapy System due to a potential compatibility issue with replacement treatment applicators.
This Class II recall affects 7 systems and 70 treatment applicators. The affected lot codes are GM0549, GM0567, GM0568, GM0569, GM0570, GM0571, and GM0577. These devices were distributed in Florida, California, and Kentucky.
The recalled product
- Product
- X80 RADiant Photoelectric Therapy System
- Manufacturer
- Xstrahl Limited
- Hazard
- device-compatibility
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Model Number: X80 RADiant Photoelectric Therapy System
- Lot Codes: GM0549
- GM0567 GM0568
- GM0569
- GM0570
- GM0571 and GM0577
- UDI/DI: 5060494200008
Distribution
Distributed in 3 states:
- CA
- FL
- KY
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