Elekta Versa HD radiation therapy system detector arm uncontrolled extension risk
Certain Elekta Versa HD radiation therapy systems may experience uncontrolled detector arm extension due to microswitch setup issues. This recall affects 451 systems worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 device recall with potential for equipment malfunction (uncontrolled detector arm extension), but no injuries or hospitalizations have been reported. Per the classification rubric, risk-of-harm products without reported injury receive a High (3) score.
Plain-English summary
Elekta, Inc. is recalling the Versa HD radiation therapy system (Ref XRT 2121, 2131) due to a microswitch defect. The microswitch, located in the middle arm, may be incorrectly set up during manufacturing. If improperly configured, this could lead to uncontrolled extension of the iViewGT/XVI detector arms. When fully deployed, the detector arm poses no risk of uncontrolled extension.
This recall affects 451 units distributed worldwide. Affected serial numbers are documented in FDA recall Z-0445-2024.
Facilities operating these systems should verify their system against the list of recalled serial numbers.
The recalled product
- Product
- ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- Manufacturer
- Elekta, Inc.
- Affected units
- 451
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 05060191071529
- Serial Numbers: 153396
- 153671
- 109003
- 153383
- 153384
- 153055
- 153980
- 154001
- 154002
- 154003
- 154004
- 154272
- 153104
- 153188
- 153243
- 153745
- 153836
- 153872
- 153876
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Elekta, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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