Z-0520-2025Class II

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR...

Name: Z-0520-2025 Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR...
Creator: GE Medical Systems, LLC
Published: 2024-10-28
License: https://open.fda.gov/license/

GE Healthcare / initiated 2024-10-28 / Open, Classified / root cause: design

FDA source

GE Medical Systems, LLC began a recall of Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR on 2024-10-28. FDA classified it as Class II and gives the reason as "Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning". 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-0520-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-28
Posted: 2024-11-22
Recalling firm: GE Healthcare
Product: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 2 units
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 codes and lots: 1) UDI/DI To be provided, System ID 82427070262; 2) UDI/DI To be provided, System ID EX0133

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0520-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0517-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-22
Z-0518-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-22
Z-0519-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-22
Z-0520-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-22

Product code LNH

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)