SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging… recallZ-0519-2025 · GE Medical Systems, LLC · initiated Oct 28, 2024

Why it was recalled

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

FDA root cause category: Device Design

What the company is doing

GE Healthcare issued an "URGENT MEDICAL DEVICE CORRECTION" notice to its consignees on 10/28/20224 delivered through a traceable means. The notice explained the issue, safety issue, and requested the following actions be taken for the continued safe usage of the affected devices: "Ensure hearing protection with a Noise Reduction Rating (NRR) of at least 33dB is used during exams on these systems. 200 pairs are provided with this letter. Please post this letter in your facility on or near the MR operator console. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records." Please complete and return the attached acknowledgement form to [email protected]. For questions or concerns, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Recall details

Recall number

Z-0519-2025

Status

Open, Classified

Initiated by the company

Oct 28, 2024

Posted by the FDA

Nov 22, 2024

Recalling firm

GE Medical Systems, LLC

Quantity

3 units

Product code

LNH

FDA submissions

K160618, K163331, K202966

Distribution

Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.

Product description

SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System

Other devices under the same FDA submission

10 devices cleared under K160618, K163331, K202966 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• NA SIGNA Artist

  GE Medical Systems, L.L.C. · System, nuclear magnetic resonance imaging
  5 recalls1 report
• NA SIGNA Architect

  GE Medical Systems, L.L.C. · System, nuclear magnetic resonance imaging
  4 recalls0 reports
• NA SIGNA Architect

  GE Medical Systems, L.L.C. · System, nuclear magnetic resonance imaging
  4 recalls0 reports
• NA SIGNA Artist

  Ge Healthcare(Tianjin) Company Limited · System, nuclear magnetic resonance imaging
  3 recalls0 reports
• NA 5767030

  GE Medical Systems, L.L.C. · System, nuclear magnetic resonance imaging
  3 recalls0 reports
• NA SIGNA Artist

  Ge Healthcare(Tianjin) Company Limited · System, nuclear magnetic resonance imaging
  2 recalls0 reports
• NA SIGNA Artist

  Ge Healthcare(Tianjin) Company Limited · System, nuclear magnetic resonance imaging
  2 recalls0 reports
• NA SIGNA Architect

  GE Medical Systems, L.L.C. · System, nuclear magnetic resonance imaging
  2 recalls0 reports
• NA 5767030-2

  GE Medical Systems, L.L.C. · System, nuclear magnetic resonance imaging
  2 recalls0 reports
• NA SIGNA Artist

  Ge Healthcare(Tianjin) Company Limited · System, nuclear magnetic resonance imaging
  2 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 95735).

• Z-0517-2025 · Open, Classified
  Discovery MR750w 3.0T, whole body magnetic resonance scanner
• Z-0518-2025 · Open, Classified
  SIGNA Architect, Nuclear Magnetic Resonance Imaging System
• Z-0520-2025 · Open, Classified
  Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,