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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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
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