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Recall Observatory FDA recall evidence

Device product

ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Z-0447-2024

October 25, 2023

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 93264
Status
Ongoing
Classification
Class II
Quantity
47 units
Official record key
device-enforcement:Z-0447-2024

Official wording

Reason: Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.

Code information: 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, 152519, 153118, 153102, 153204, 153166, 152017, 152112, 152325, 152749, 152754, 152755, 152756, 152860, 153006, 151874, 152538, 152839, 152921, 153149, 153267, 152736, 151793, 151802, 151812, 151960, 152600, 152678, 152838

Distribution pattern: worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.