Quick Facts at a Glance
- Recall Date
- August 28, 2025
- Hazard Level
- HIGH
- Brand
- Siemens Medical Solutions USA
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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 Magnet System
- Model numbers
- Model Number: 10655588. UDI Numbers: (01)04056869006796(21)56069. Serial Numbers: 56069.
- Sold at
- Unknown
- 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. Pressure buildup may rupture the containment system and release helium into the scanning room.
Industry Context
This recall is not described as part of a broader pattern in the provided data.
Real-World Impact
A single unit recall with high risk suggests urgent action for any affected facility. Replacement or repair is determined by Siemens and may affect ongoing imaging services.
Practical Guidance
How to identify if yours is affected
- Check model number 10655588 and serial number 56069.
- Confirm if device is part of the worldwide distribution in the recall.
Where to find product info
Model, serial numbers, and UDI are typically on the device nameplate and in the EHR system’s asset record.
What timeline to expect
Refund or repair timelines will be provided by Siemens after notification; typical hospital recall operations can span weeks to months.
If the manufacturer is unresponsive
- Escalate to hospital risk management.
- Contact Siemens Medical Solutions USA customer support for official guidance.
- File an FDA safety report if you believe there is imminent danger.
How to prevent similar issues
- Maintain updated recall communications with the manufacturer.
- Document all recall communications and device status changes.
Documentation advice
Keep a copy of the recall notice, all correspondence with Siemens, and any service records related to the device.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product: MAGNETOM Spectra (CN). Model Number: 10655588. Distribution: Worldwide. Recall date: 2025-08-28. Status: Active. Quantity: 1 unit.
Reported Incidents
No specific injuries or incidents are described in the provided data. The recall is classified as Class I with a high hazard level due to potential catastrophic failure.
Key Facts
- Classification: Class I recall
- Hazard: Ice blockage in magnet venting system leading to helium leak during quench
- Global distribution including US and 70+ countries
- Status: Active as of 2025-10-08
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.