The Recall Desk
HighFDA (Devices)·Z-2479-2024·Announced 2024-08-14

GE SIGNA Prime MR system can exceed RF safety limits in Low SAR mode

GE Medical Systems is recalling 72 SIGNA Prime MR imaging systems worldwide. Under specific imaging conditions, the systems can exceed prescribed radiofrequency safety limits, potentially causing MR conditional implants to overheat.

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: FDA Class II recall with no reported illnesses or injuries. The potential hazard—overheating of MR conditional implants under specific technical conditions—remains theoretical, meeting the criterion for High severity: a risk-of-harm medical device where injury has not yet been reported.

Plain-English summary

GE Medical Systems is recalling 72 SIGNA Prime MR imaging systems distributed worldwide. The systems have a software issue that can cause radiofrequency (RF) output to exceed the prescribed safety limit during certain imaging protocols.

The problem occurs when using 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences with the Optimized T2 FLAIR option turned off or not included in the system configuration, while operating in Low SAR Mode. Under these specific conditions, the system's predicted B1+ Root Mean Square (RMS) value can exceed the user-prescribed limit, potentially resulting in overheating of MR conditional implants.

The affected systems are identified by specific System IDs and serial numbers provided by the FDA. Healthcare facilities operating SIGNA Prime MR systems should verify whether their equipment is included in this recall.

The recalled product

Product
SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Magnetic Resonance Imaging System
Hazard
Affected units
72

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: 662335PRIME
  • DZ2423MR01
  • DZ4388MR01
  • DZ3836MR01
  • MR6345AR
  • MR8657AR
  • MR1612AR
  • MR3084AR
  • MR7154AR
  • MRPM0464
  • MR51928141
  • 8.30276E+13
  • MRPM1206
  • MRPM0798
  • MRPM0933
  • MRPM1282
  • MRPM0601
  • MRPM0960
  • MRPM0944
  • MRPM0725

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 →

Related recalls

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Same hazard · implant overheating

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