Medical radiation therapy system detector arm extension recall
Elekta recalls Infinity radiation therapy systems for a detector arm defect that could cause uncontrolled extension if a microswitch is improperly configured. No injuries reported.
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: Risk-of-harm medical device with potential for uncontrolled detector arm extension. Hazard is conditional (only if microswitch incorrectly configured) and mitigatable (no risk when arms fully deployed). No illnesses or injuries reported, satisfying the criterion: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Elekta, Inc. is recalling 291 units of the Elekta Infinity radiation therapy system (models XRT 0511, XRT 0521, XRT 0531, XRT 0541) distributed worldwide. The affected systems have specific serial numbers listed in FDA recall Z-0446-2024.
Elekta identified a potential defect involving the microswitch within the middle arm of the system. If this microswitch is incorrectly set up during installation or maintenance, the iViewGT/XVI detector arms could extend in an uncontrolled manner. However, when the detector arms are fully deployed, there is no risk of uncontrolled extension. No illnesses or injuries have been reported associated with this issue.
Healthcare facilities operating affected systems should contact Elekta for guidance on verifying correct microswitch configuration. Affected facilities can identify their systems using the serial numbers and UDI codes provided in the FDA recall notice.
The recalled product
- Product
- ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- Manufacturer
- Elekta, Inc.
- Hazard
- uncontrolled-extension
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 05060191071512
- Serial Numbers: 153451
- 154067
- 154072
- 153600
- 153693
- 152596
- 152649
- 152834
- 152956
- 152957
- 153005
- 153054
- 153377
- 153593
- 153602
- 153617
- 153852
- 154048
- 154049
Distribution
Distribution scope not specified by the agency.
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