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Open, Classified

Discovery MR750w 3.0T

FDA Recall Z-2132-2025 · Posted 2025-07-18

Recalling FirmGE Medical Systems, LLC
Recall StatusOpen, Classified
Product CodeLNH
Date Initiated2025-05-23

Reason for Recall

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

Firm Action

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION to its consignees on 05/23/2025 delivered using traceable means. The notice explained the issue, risk, and requested the following: Actions to be taken by Customer/User: You can continue to use your MR system by following the instructions below: 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].

Root Cause

Device Design

Distribution Pattern

Worldwide distribution - US Nationwide and the country of China.

Official Source

View FDA Recall →

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

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