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Open, Classified

X80 RADiant Photoelectric Therapy System

FDA Recall Z-1404-2022 · Posted None

Recalling FirmXstrahl Limited
Recall StatusOpen, Classified
Product CodeJAD
Date Initiated2022-04-27
Product Quantity7 devices; 70 treatment applicators

Reason for Recall

There is a potential compatibility issue with the systems and replacement treatment applicators.

Firm 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.

Root Cause

Finished device change control

Distribution Pattern

US Distribution FL, CA, KY

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172080Photoelectric Therapy SystemXstrahl, Ltd. · 2017-09-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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