The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1561-2016·Announced 2016-05-04

Elekta Radionuclide Radiation Therapy System Recalled for Frame Adapter Latch Defect

Elekta is recalling 217 Radionuclide Radiation Therapy Systems because frame adapter latches can lock without proper pin insertion, potentially compromising treatment accuracy.

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: The recall involves a medical device defect that could compromise treatment accuracy, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Elekta, Inc. is recalling 217 units of the Radionuclide Radiation Therapy System, a teletherapy device intended for stereotactic irradiation of head structures. The recall is due to a defect in the frame adapter where the latches can be locked even if the locating pins are not inserted into the corresponding holes in the coordinate frame.

This defect could potentially affect the accuracy of the stereotactic irradiation procedure. The affected devices were distributed worldwide, including in the United States and numerous international countries. The source text does not report any specific injuries or illnesses associated with this defect.

Healthcare facilities and users of these devices should contact Elekta, Inc. for instructions on how to address the defect. Consumers are not directly affected as this is a professional medical device used in clinical settings.

The recalled product

Product
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiation Therapy Equipment
Hazard
Affected units
217

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)

  • Perfexion - 14753-099/6052
  • 12579-007/6250
  • 10394-LGK01/6144
  • 11920-C5210/6088
  • 17397-001/6158
  • 105528-001/6122
  • 14857-001/6028
  • 12236-006/6097
  • 12473-003/6005
  • 16867-001/6166
  • 12668-003/6145 10208-003/6215
  • 10698-001/6237
  • 10979-002/6213
  • 10316-500/6210
  • 21061-001/6195
  • 20364-001/6103
  • 11720-002/6143
  • 12620-002/6120
  • 10611-001/6081
  • 12846-004/6064

Distribution

Distributed nationwide across the United States.

The notice also names 36 states specifically:

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