Medical Radiation Therapy Device Microswitch May Cause Uncontrolled Detector Arm Extension
Elekta radiation therapy accelerators may experience uncontrolled detector arm extension due to an incorrectly set microswitch in the middle arm. The issue affects 315 units 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: FDA Class II device with potential for mechanical malfunction (uncontrolled detector arm extension), but no injuries or illnesses reported. Per the severity rubric, risk-of-harm medical products without reported injuries score as High.
Plain-English summary
Elekta, Inc. is recalling approximately 315 units of the Precise Digital Accelerator (REF MRT 6001, MRT 6011) radiation therapy systems distributed worldwide. These medical devices are used for charged-particle radiation therapy treatment.
The recall addresses a potential equipment malfunction: if the microswitch within the middle arm is incorrectly set up, the iViewGT/XVI detector arms may extend in an uncontrolled manner. However, when the detector arm is fully deployed, no risk of uncontrolled extension exists.
Users and healthcare facilities operating affected devices are urged to verify the microswitch setup according to Elekta's guidance. The specific serial numbers of affected units are provided in the full recall notice. Users should contact Elekta for technical guidance if they believe their device may be affected.
The recalled product
- Product
- ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- Manufacturer
- Elekta, Inc.
- Hazard
- uncontrolled-extension
- 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 none
- Serial Numbers: 152320
- 105566
- 152018
- 152077
- 152078
- 152142
- 152196
- 152326
- 152327
- 152328
- 152434
- 152493
- 152552
- 152640
- 152680
- 152922
- 152940
- 152943
- 153244
Distribution
Distribution scope not specified by the agency.
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