FDA Medical devices recall ·
Tomographic Imager Combining Emission Computed Tomography With Nuclear… recall
- Recall number
- Z-0520-2025
- Date
- (initiated October 28, 2024)
- Company / brand
- GE Medical Systems, LLC
3200 N Grandview Blvd, Waukesha, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
Why was it recalled?
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) UDI/DI To be provided, System ID 82427070262; 2) UDI/DI To be provided, System ID EX0133
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0520-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.