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Open, Classified

SIGNA Architect, Nuclear Magnetic Resonance Imaging System

FDA Recall Z-0518-2025 · Posted 2024-11-22

Recalling FirmGE Medical Systems, LLC
Recall StatusOpen, Classified
Product CodeLNH
Date Initiated2024-10-28
Product Quantity53 units

Reason for Recall

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

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K202966SIGNA ArchitectGe Healthcare (Ge Medical Systems, LLC) · 2020-11-13K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA ArtistGe Medical Systems, LLC · 2017-03-17K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TGe Medical Systems, LLC · 2016-06-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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