Medical Radiation Therapy System Detector Arm Malfunction Poses Uncontrolled Extension Risk
Elekta recalled its ELEKTA AXESSE radiation therapy system due to potential uncontrolled extension of detector arms if the microswitch is incorrectly configured. The recall affects 47 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a risk-of-harm scenario where mechanical malfunction could occur if the device is incorrectly configured. No actual injuries, illnesses, or deaths have been reported, and the manufacturer confirms the hazard is eliminated when the device is properly deployed.
Plain-English summary
Elekta, Inc. is recalling 47 units of its ELEKTA AXESSE charged-particle radiation therapy system accelerator (model references XRT 2181 and XRT 27891) distributed worldwide. This medical device is used for radiation therapy.
The recall was initiated after Elekta identified that if the microswitch within the middle arm is incorrectly setup, there is potential for uncontrolled extension of the iViewGT / XVI detector arms. According to Elekta, when the detector arm is fully deployed, there is no risk of uncontrolled extension.
The recall affects 47 specific units identified by serial number in the FDA recall notice Z-0447-2024.
The recalled product
- Product
- ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- Manufacturer
- Elekta, Inc.
- Hazard
- mechanical-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI N/A
- Serial Numbers: 152140
- 152617
- 152691
- 152004
- 152683
- 152994
- 153935
- 152620
- 152809
- 152854
- 152867
- 152885
- 152964
- 152974
- 153192
- 153217
- 153527
- 152499
- 153668
Distribution
Distribution scope not specified by the agency.
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