The Recall Desk
HighFDA (Devices)·Z-0443-2024·Announced 2023-12-13

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.
Category
Medical Device — Radiation Therapy Equipment
Hazard
Affected units
1,019

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.

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.

See all 6 products in this recall →

Related recalls

Same manufacturer · Elekta, Inc.

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