CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report
Tomographic Imager Combining Emission Computed Tomography recalled
GE Medical Systems is recalling Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic, distributed nationwide in the US. The recall was initiated on 28 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0520-2025
- FDA event ID
- 95735
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Oct 2024
- FDA classified
- 22 Nov 2024
- Reported
- 4 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 Oct 2024 | Recall initiated by company | |
| 22 Nov 2024 | Classified by FDA | +25 days |
| 4 Dec 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
Where it was distributed
Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
Questions about this recall
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.
Which lots are affected?
1) UDI/DI To be provided, System ID 82427070262; 2) UDI/DI To be provided, System ID EX0133
Where was it sold?
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 should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 95735This product is part of a recall event; the main page for the event is Signa Architect AIR, Nuclear Magnetic Resonance Imaging System recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Signa Architect AIR, Nuclear Magnetic Resonance Imaging System recalled | GE Medical Systems | Other | Nationwide | |
| CLASS II | Discovery MR750w 3.0T, whole body magnetic resonance scanner recalled | GE Medical Systems | Other | Nationwide | |
| CLASS II | Signa Architect, Nuclear Magnetic Resonance Imaging System recalled | GE Medical Systems | Other | Nationwide |
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