X80 RADiant Photoelectric Therapy System recallZ-1404-2022 · Xstrahl Limited · initiated Apr 27, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Xstrahl Limited or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential compatibility issue with the systems and replacement treatment applicators.
FDA root cause category: Finished device change control
What the company is doing
The firm sent out the recall notification on 04/27/2022 via email. The letter mentions the consignee is able to continue to use the system. The consignee is to ensure that the verification of selection of the correct applicator for the planned treatment is conducted with the consignee's procedures and radiotherapy professional practice and guidelines. They are asked to complete a response form and return it no later than 30 days.
Recall details
- Recall number
- Z-1404-2022
- Status
- Open, Classified
- Initiated by the company
- Apr 27, 2022
- Recalling firm
- Xstrahl Limited
- Quantity
- 7 devices; 70 treatment applicators
- Product code
- JAD
- FDA submissions
- K172080
- Distribution
- US Distribution FL, CA, KY
Product description
X80 RADiant Photoelectric Therapy System
Code information (models, lots, serial numbers)
Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Xstrahl Photoelectric Therapy SystemXstrahl Limited · System, Therapeutic, X-Ray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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