FDA Medical Device Recalls (openFDA)
Xstrahl Limited: X80 RADiant Photoelectric Therapy System
- Recall number
- Z-1404-2022
- Recalling firm
- Xstrahl Limited
- Product
- X80 RADiant Photoelectric Therapy System
- Status
- Open, Classified
- Initiated
- 2022-04-27
- Posted
- not on file
- Terminated
- not on file
- Reason
- There is a potential compatibility issue with the systems and replacement treatment applicators.
- Root cause
- Finished device change control
- Action
- 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.
- Quantity
- 7 devices; 70 treatment applicators
- Distribution
- US Distribution FL, CA, KY
- Lot, serial or model codes
- Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008
- 510(k) numbers
- ["K172080"]
- PMA numbers
- not on file
- Product code
- JAD
- Firm FEI
- 3004561814
- Firm city
- Walsall
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28