The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2460-2024·Announced 2024-08-14

GE SIGNA Pioneer MR Systems May Overheat Patient Implants During Scanning

GE SIGNA Pioneer MR systems with certain software versions may allow radiofrequency exposure to exceed prescribed limits in Low SAR Mode when using specific imaging sequences, potentially causing overheating of MR conditional implants.

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 is classified as FDA Class II. Although no illnesses or injuries have been reported in the source text, the hazard presents a potential risk of harm—overheating of patient implants—where injury has not yet occurred, consistent with the criteria for High severity.

Plain-English summary

GE Medical Systems has issued a recall of SIGNA Pioneer Nuclear Magnetic Resonance (MR) imaging systems. The affected devices have software versions PX25.0 through PX25.5, PX26.0, PX26.1, PX28.0 through PX28.4, PX29.0, PX29.1, MR30.0, and MR30.1. Approximately 956 units have been distributed worldwide.

The issue occurs when the system operates in Low SAR Mode with a 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequence selected, and the Optimized T2 FLAIR sequence option is turned off or not included in the system configuration. Under these conditions, the system's predicted radiofrequency field strength (B1+RMS) value can exceed the user-prescribed limit.

This radiofrequency overexposure can result in overheating of MR conditional implants in patients undergoing MRI procedures. Patients with MR conditional implants are potentially affected.

The FDA classified this as a Class II recall.

The recalled product

Product
SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
956

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)

  • System ID: 520744MR
  • 714578MR1
  • RADNETMR1727
  • RADNETMR652
  • 951486MR2
  • RADNETMR651
  • 831RMGMR1
  • RADNETMR647
  • RADNETMR661
  • 720442MR
  • 303508MR
  • 860584MR3T
  • 203694MR3T
  • 860678MR3T
  • 860545MR3T
  • 860536MR3T
  • 203327MR3T
  • 860871MR3T
  • 203949MR3T
  • 305933MR1

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 26 recalled by GE Medical Systems, LLC 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 26 products in this recall →

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