Z-2133-2025Class II

Signa Pet/mr

Name: Z-2133-2025 Signa Pet/mr
Creator: GE Medical Systems, LLC
Published: 2025-05-23
License: https://open.fda.gov/license/

GE Healthcare / initiated 2025-05-23 / Open, Classified / root cause: design

FDA source

GE Medical Systems, LLC began a recall of SIGNA PET/MR on 2025-05-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2133-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-23
Posted: 2025-07-18
Recalling firm: GE Healthcare
Product: Signa Pet/mr
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
Root cause tag: design
FDA root cause: Device Design
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].
Distribution: Worldwide distribution - US Nationwide and the country of China.
Product codes and lots: GTIN: 00840682105378

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2133-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2130-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-18
Z-2131-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-18
Z-2132-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-18
Z-2133-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-18

Product code LNH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)