Device recall: Discovery MR750w 3.0T, whole body magnetic resonance scanner
Class II FDA enforcement event 95735. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
GE Medical Systems, LLC started this device recall on 28 Oct 2024. The firm address in the FDA record is in Waukesha, WI. FDA put the recall in Class II. FDA event 95735 has 4 product records. The first FDA enforcement report date is 4 Dec 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
Recalling firm
GE Medical Systems, LLC, Waukesha, WI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0517-2025 | Discovery MR750w 3.0T, whole body magnetic resonance scanner | 8 units | Class II | Ongoing | 4 Dec 2024 |
| Z-0518-2025 | SIGNA Architect, Nuclear Magnetic Resonance Imaging System | 53 units | Class II | Ongoing | 4 Dec 2024 |
| Z-0519-2025 | SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System | 3 units | Class II | Ongoing | 4 Dec 2024 |
| Z-0520-2025 | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR, | 2 units | Class II | Ongoing | 4 Dec 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 4Median of the firm: 3
- Events of the firm on the register
- 42
Other events of the firm
Official channels
- FDA enforcement report Z-0517-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 95735. https://recallregister.com/fda/ii/95735/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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 quantity of product is in FDA event 95735?
- The event has 4 product records. The first record gives this quantity:
8 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.