Quick Facts at a Glance
- Recall Date
- August 28, 2025
- Hazard Level
- HIGH
- Brand
- Siemens Medical Solutions USA
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Siemens Medical Solutions USA
- Product type
- MRI System
- Model numbers
- Model Number: 10684334, (01)04056869006680(21)162012, (01)04056869006680(21)162055, (01)04056869006680(21)162039, (01)04056869006680(21)162002, (01)04056869006680(21)162014, (01)04056869006680(21)162069, (01)04056869006680(21)162083 +13 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 28, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for instructions. Notification method: Letter
Why This Is Dangerous
Ice blockage in the magnet venting system can prevent helium from escaping during a quench. The resulting pressure buildup could rupture the helium containment and cause a helium leak into the scanning room.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals may experience imaging downtime and need to coordinate with Siemens for service actions. The recall presents potential safety risks during device operation and requires immediate stop-use actions.
Practical Guidance
How to identify if yours is affected
- Verify model number on the device label is 10684334.
- Review the list of UDIs provided in the recall notice and compare to your device's UDI on the nameplate.
- If affected, halt use and contact Siemens Medical Solutions USA for instructions.
Where to find product info
Device nameplate, hospital procurement records, and the FDA recall page linked in the notice.
What timeline to expect
Service actions and replacements will be scheduled by Siemens with the hospital. No general refund window is published.
If the manufacturer is unresponsive
- Escalate with hospital administration or biomedical engineering.
- File a complaint with the FDA if the facility experiences delays or safety concerns.
How to prevent similar issues
- For future MRI equipment purchases, verify venting and quench safety features with the OEM.
- Maintain updated service agreements with manufacturers and monitor recall notices from FDA and OEMs.
Documentation advice
Keep a copy of the recall notice, record all communications with Siemens, and document any actions taken with the device.
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Product Details
Model numbers and identifiers for this recall include Model Number 10684334 and multiple UDIs. The devices were distributed Worldwide, including US Nationwide and numerous countries listed by the FDA recall notice. Sold to hospitals and healthcare facilities. No price information available.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- UDIs include 19 listed identifiers
- Global distribution to US hospitals and country list
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Safety Guide
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