Radiation Therapy System Detector Arm Microswitch Defect May Cause Uncontrolled Extension
Elekta is recalling 264 units of its Synergy Platform radiation therapy systems due to a microswitch defect that could cause uncontrolled extension of detector arms. The systems were distributed 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 a risk-of-harm medical device where no illnesses or injuries have been reported and the hazard is theoretical rather than realized. Although classified as Class II by the FDA, the absence of reported hospitalizations means it does not meet the Severe threshold, placing it at High severity per the rubric.
Plain-English summary
Elekta is recalling 264 units of the Elekta Synergy Platform (REF MRT 8501 and MRT 8511), a medical charged-particle radiation therapy system accelerator used in cancer treatment. These units were distributed worldwide.
The company has identified a potential defect in the microswitch within the middle arm. If this microswitch is incorrectly set up, the iViewGT/XVI detector arms could extend uncontrollably during operation. Such uncontrolled extension poses a potential risk to patients and clinical staff in the treatment room.
Affected units can be identified by their UDI/DI codes and specific serial numbers listed in the recall notice. Notably, there is no risk of uncontrolled extension when the detector arm is fully deployed.
Facilities operating these systems should verify that the microswitch is correctly configured according to Elekta's setup instructions. Contact Elekta immediately if your facility uses one of the affected devices.
The recalled product
- Product
- ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- Manufacturer
- Elekta, Inc.
- Affected units
- 264
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 05060191071536
- Serial Numbers: 152110
- 153550
- 153363
- 152650
- 151851
- 153300
- 152721
- 152816
- 152539
- 153879
- 154099
- 154121
- 154230
- 154581
- 151909
- 152186
- 152314
- 152542
- 152728
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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