Medical Radiation Therapy System Potential Detector Arm Malfunction Due to Microswitch Issue
Recall of approximately 1,019 Elekta Synergy radiation therapy systems due to potential uncontrolled extension of detector arms if the middle arm microswitch is incorrectly setup.
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: Class II medical device recall for a specific mechanical hazard (detector arm extension risk) without reported illnesses or injuries. Per the rubric, risk-of-harm products without reported injury are scored at 3 (High).
Plain-English summary
The Elekta Synergy radiation therapy system (models REF MRT 8501, MRT 8511) has been identified as having a potential hazard affecting approximately 1,019 units distributed worldwide. The issue involves the middle arm microswitch which, if incorrectly setup, could result in uncontrolled extension of the detector arms during treatment.
According to the manufacturer, when the detector arm is fully deployed, there is no risk of uncontrolled extension. Healthcare facilities using affected equipment should contact Elekta, Inc. for inspection and guidance on remedial actions. This is a Class II FDA medical device recall.
The recalled product
- Product
- ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- Manufacturer
- Elekta, Inc.
- Hazard
- detector-arm-extension
- mechanical-defect
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 05060191071505
- Serial Numbers: 154549
- 151917
- 151963
- 152072
- 152081
- 152131
- 152382
- 151838
- 152318
- 152807
- 151951
- 152416
- 153147
- 153148
- 153963
- 151821
- 151845
- 151940
- 152160
Distribution
Distribution scope not specified by the agency.
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