Siemens MAGNETOM Skyra MRI System Recall Covers 182 Units Over Ice Blockage Risk

How to identify if yours is affected

1. Identify model 10432915 and verify against UDI numbers.
2. Cross-check with listed 510(k) numbers.
3. Confirm product serials and date codes match recall records.

Where to find product info

Refer to the FDA recall page and Siemens notice for exact identifiers like UDI and model numbers.

What timeline to expect

Remediation timelines vary by facility, commonly 4-8 weeks for service arrangements.

If the manufacturer is unresponsive

• Document every contact attempt.
• Escalate to regional Siemens service manager or corporate safety office.
• Consider filing a complaint with the FDA if service delays occur.

How to prevent similar issues

• For MRI systems, ensure venting pathways are clear during maintenance.
• Schedule regular venting system inspections.
• Verify that water or ice formation risks are mitigated in room design and maintenance.

Documentation advice

Maintain copies of all correspondence, service orders, and equipment status before and after remediation.