The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1675-2023·Announced 2023-06-14

Elekta Unity Image-Guided Radiation Therapy System Electrical Connector Overheating Risk

Elekta, Inc. is recalling 18 Elekta Unity Image-Guided Radiation Therapy Systems due to a potential electrical connector overheat hazard in the MR gradient coil. No injuries have been reported.

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 recall addresses a risk-of-harm scenario in a Class II medical device—an electrical connector with potential to overheat—without any reported injuries to date. Although the source characterizes the risk as a 'low possibility,' the potential safety hazard in a critical medical device warrants a High severity rating.

Plain-English summary

Elekta, Inc. is recalling 18 Elekta Unity Image-Guided Radiation Therapy Systems containing MR gradient coils. These systems were distributed nationwide in Florida, Iowa, New Jersey, New York, Oklahoma, Pennsylvania, Tennessee, Wisconsin, Michigan, Louisiana, Kansas, New Mexico, and Texas.

The recall is due to a low possibility that an electrical connector in the MR gradient coil may overheat on affected units. This potential electrical hazard could pose a safety risk. No injuries or adverse events have been reported to date.

The affected systems can be identified by their unique serial numbers specified in FDA recall notice Z-1675-2023. Healthcare facilities operating these systems should contact Elekta, Inc. for guidance on inspection and corrective measures.

The recalled product

Product
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Manufacturer
Elekta, Inc.
Category
Medical Device — Image-Guided Radiation Therapy
Hazard
Affected units
18

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 (19)

  • UDI GTIN 05060191071598
  • serial numbers: 14117-007/600034
  • 10632-010/600036
  • 10817-011/600010
  • 10905-008/600037
  • 11198-010/600047
  • 11198-011/600048
  • 11830-010/600064
  • 11888-004/600072
  • 12108-007/600019
  • 13371-002/600021
  • 13553-006/600003
  • 30003193-003/600074
  • 13120-017/600073
  • 11328-019/600059
  • 14232-001/600095
  • 12269-004/600100
  • 11008-003/600104
  • 13212-007/600106

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

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