GE Medical Systems, LLC: Medical Device Recall in 2024 - (Recall #: Z-0520-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,

Product Classification:

Class II

Date Initiated: October 28, 2024

Date Posted: December 4, 2024

Recall Number: Z-0520-2025

Event ID: 95735

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.

Status: Ongoing

Product Quantity: 2 units

Code Information:

1) UDI/DI To be provided, System ID 82427070262; 2) UDI/DI To be provided, System ID EX0133

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.

Voluntary or Mandated:

Voluntary: Firm initiated