X80 RADiant Photoelectric Therapy System recall
X80 RADiant Photoelectric Therapy System
Why was X80 RADiant Photoelectric Therapy System recalled?
There is a potential compatibility issue with the systems and replacement treatment applicators.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008
- Product
- X80 RADiant Photoelectric Therapy System
- Recalling firm
- Xstrahl Limited
- Quantity
- 7 devices; 70 treatment applicators
- Distribution
- US Distribution FL, CA, KY
- Recall date
- July 27, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)