Xstrahl Photoelectric Therapy SystemRecalls & reported problems
Xstrahl Limited · Xstrahl Photoelectric Therapy System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Apr 27, 2022Class IIOpen, Classified
There is a potential compatibility issue with the systems and replacement treatment applicators.
Z-1404-2022 · Root cause: Finished device change control · Recall details · FDA record ↗
Other System, Therapeutic, X-Ray devices
- INTRABEAM® Spherical Applicator 1.5 cm 304534-6000-557Carl Zeiss Meditec AG · System, Therapeutic, X-Ray1 recall0 reports
- INTRABEAM® Needle Applicator 304534-3001-200Carl Zeiss Meditec AG · System, Therapeutic, X-Ray1 report
- Balloon Applicator Kit 720342Icad, Inc. · System, Therapeutic, X-Ray1 death1 report
- X80 / RADiant / PhotoElectric Therapy System RADiant AuraXstrahl Limited · System, Therapeutic, X-Ray1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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