—#214285

Product

SIGNA PET/MR

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: GTIN: 00840682105378

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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 recall.60999@gehealthcare.com.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3200 N Grandview Blvd, Waukesha, Wisconsin 53188-1693

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the country of China.

Timeline

Recall initiated: 2025-05-23
Posted by FDA: 2025-07-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214285. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.