OARtrac ORB-60FRecalls & reported problems
Radiadyne, L.L.C. · OARtrac Disposable Gas Release Short Profile Prostate Immobilization Treatment Balloon Device Kit, with Fiducial Marker and PSD Sensor Bundle · Class 2
All models of OARtrac (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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.
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 16, 2026.
Recalls naming this device
- Nov 19, 2019Terminated
May result in readings outside of the expected accuracy range.
Z-0709-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Dosimeter, Ionizing Radiation, Implanted devices
- OARtrac OT-CDU2PRadiadyne, L.L.C. · Dosimeter, Ionizing Radiation, Implanted1 recall0 reports
- Electron microPSD PSD-EE5NRadiadyne, L.L.C. · Dosimeter, Ionizing Radiation, Implanted1 recall0 reports
- Photon MicroPSD PSD-PE5NRadiadyne, L.L.C. · Dosimeter, Ionizing Radiation, Implanted1 recall0 reports
- HDR microPSD PSD-HB5NRadiadyne, L.L.C. · Dosimeter, Ionizing Radiation, Implanted1 recall0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page