CLASS II ONGOING Device recall · Reported 30 Jul 2025 · FDA Enforcement Report
Discovery MR750w 3.0T recalled by GE Medical Systems
GE Medical Systems is recalling Discovery MR750w 3.0T, distributed nationwide in the US. The recall was initiated on 23 May 2025 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-2132-2025
- FDA event ID
- 97030
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 May 2025
- FDA classified
- 18 Jul 2025
- Reported
- 30 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 23 May 2025 | Recall initiated by company | |
| 18 Jul 2025 | Classified by FDA | +56 days |
| 30 Jul 2025 | 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
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Product as listed by the FDA
Discovery MR750w 3.0T
Where it was distributed
Worldwide distribution - US Nationwide and the country of China.
Questions about this recall
Why was it recalled?
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Which lots are affected?
GTIN: 00840682103817 00195278229519
Where was it sold?
Worldwide distribution - US Nationwide and the country of China.
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 97030This product is part of a recall event; the main page for the event is Signa Architect recalled by GE Medical Systems.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Signa Architect recalled by GE Medical Systems | GE Medical Systems | Other | Nationwide | |
| CLASS II | Signa Architect AIR recalled by GE Medical Systems | GE Medical Systems | Other | Nationwide | |
| CLASS II | Signa PET/MR recalled by GE Medical Systems | GE Medical Systems | Other | Nationwide |
More recalls from GE Medical Systems
All 160| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Optima XR240amx, Mobile Digital Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Optima XR220amx, Mobile Digital-Ready Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Optima XR200amx, Mobile Digital-Ready Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Giraffe OmniBed Field Replaceable Unit (FRU) recalled | GE Medical Systems | Other | Nationwide |
| Device | CLASS II | Allia IGS 7 Pulse angiographic X-ray system recalled | GE Medical Systems | Other | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |