CLASS II ONGOING Device recall · Reported 5 Mar 2025 · FDA Enforcement Report
Brivo MR355, NMRI system recalled by GE Healthcare (China) Co
GE Healthcare (China) is recalling Brivo MR355, NMRI system, distributed nationwide in the US. The recall was initiated on 31 Jan 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-1240-2025
- FDA event ID
- 96311
- Recalling firm
- GE Healthcare (China), Beijing, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Jan 2025
- FDA classified
- 27 Feb 2025
- Reported
- 5 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 31 Jan 2025 | Recall initiated by company | |
| 27 Feb 2025 | Classified by FDA | +27 days |
| 5 Mar 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
Product as listed by the FDA
Brivo MR355, NMRI system
Where it was distributed
Domestic US distribution nationwide. International distribution worldwide.
Questions about this recall
Why was it recalled?
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
Which lots are affected?
Brivo MR355 (No UDI) System IDs 082427010096 082427020046 082427040126 082427070076 082427070077 082427070170 082427100245 082427120151 082427180030 082427210147 082427210148 082427220025 082427220045 082427230060 082427240060 082427310104 0856270058 0856270059 MRR10200 MRR9920 RU1063MR03 RU8902MR01 (Updated 12/29/25 - Additional System ID 83027805544513) (Updated 1/28/26 - Additional System IDs: 82427220047 82427240055 82427070163 82427060068 82427140137 82427010122 82427280018) (Updated 2/19/26: Additional System ID EG1736MR02)
Where was it sold?
Domestic US distribution nationwide. International distribution worldwide.
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
4 other products · FDA event 96311| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Signa Creator, Signa Explorer, Nmri systems recalled | GE Healthcare (China) | Other | Nationwide | |
| CLASS II | Signa MR355, Signa MR360, Nmri system recalled | GE Healthcare (China) | Other | Nationwide | |
| CLASS II | Signa MR380, Nmri system, Non-US Only recalled | GE Healthcare (China) | Other | Nationwide | |
| CLASS II | Optima MR360, NMRI system recalled by GE Healthcare (China) Co | GE Healthcare (China) | Other | Nationwide |
More recalls from GE Healthcare (China)
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Optima MR360, NMRI system recalled by GE Healthcare (China) Co | GE Healthcare (China) | Other | Nationwide |
| Device | CLASS II | Signa MR380, Nmri system, Non-US Only recalled | GE Healthcare (China) | Other | Nationwide |
| Device | CLASS II | Signa MR355, Signa MR360, Nmri system recalled | GE Healthcare (China) | Other | Nationwide |
| Device | CLASS II | Signa Creator, Signa Explorer, Nmri systems recalled | GE Healthcare (China) | Other | Nationwide |
| Device | CLASS II | GE Healthcare Operator Console Upgrade Types recalled | GE Healthcare (China) | Packaging Defects |
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