The Recall Desk
HighFDA (Devices)·Z-0518-2025·Announced 2024-12-04

GE SIGNA Architect MRI Systems Recalled for Elevated Acoustic Noise

GE Medical Systems is recalling certain SIGNA Architect MRI systems because their gradient coils can produce elevated acoustic noise during scanning under specific conditions, potentially risking hearing damage.

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 device recall with potential for hearing damage from elevated acoustic noise during scanning operations. No illnesses or injuries have been reported to date, but this qualifies as a risk-of-harm product where injury has not yet been reported, per the severity rubric.

Plain-English summary

GE Medical Systems, LLC, is recalling certain SIGNA Architect MRI (Nuclear Magnetic Resonance) systems whose gradient coils can produce elevated acoustic noise during scanning under specific conditions.

The recalled systems are distributed worldwide across the United States and 12 other countries including Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan. Fifty-three specific units have been identified with this issue. The elevated acoustic noise poses a potential risk of hearing damage to patients and clinical staff during MRI scanning operations.

Facilities operating affected SIGNA Architect systems should identify affected units and contact GE Medical Systems, LLC. Information about specific affected systems, including their UDI (Unit Identification Numbers) and System IDs, is available through the FDA recall notice.

The recalled product

Product
SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
Affected units
53

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 (01)00840682147095(11)240100(21)PG75M2400278SC
  • System ID 303467MR2
  • UDI/DI To be provided
  • System ID 1000005000
  • UDI/DI (01)00840682147095(11)220800(21)PG75M2300225SC
  • System ID 217528MR4
  • UDI/DI (01)00840682147095(11)220600(21)PG75M2200130SC
  • System ID 781SSHMR3
  • System ID 301295AMR2
  • System ID GON90303794
  • System ID 215955HON3T
  • UDI/DI (01)00840682147095(11)230600(21)PG75M2300245SC
  • System ID 806UMCHWMR3T
  • UDI/DI (01)00840682147095(11)230800(21)PG75M2300255SC
  • System ID 703573ARC7
  • UDI/DI (01)00840682122702(11)220100(21)PG75A2300133SC
  • System ID 757953SPMR
  • UDI/DI (01)00840682147095(11)231000(21)PG75M2300263SC
  • System ID 905684MR3T
  • UDI/DI (01)00840682147095(11)220800(21)PG75M2200153SC

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same manufacturer · GE Medical Systems, LLC

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Same hazard · acoustic noise

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