🔍 RecallPedia

MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

Class I - Dangerous
🏥 Medical Devices Recalled: August 28, 2025 Siemens Medical Solutions USA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number: 11516217. UDI Numbers: (01)04056869299273(21)212087, (01)04056869299273(21)212098, (01)04056869299273(21)212088, (01)04056869299273(21)212068, (01)04056869299273(21)212081, (01)04056869299273(21)212018, (01)04056869299273(21)212041, (01)04056869299273(21)212038, (01)04056869299273(21)212047, (01)04056869299273(21)212019, (01)04056869299273(21)212037, (01)04056869299273(21)212032, (01)04056869299273(21)212049, (01)04056869299273(21)212017, (01)04056869299273(21)212064, (01)04056869299273(21)212096, (01)04056869299273(21)212065, (01)04056869299273(21)212016, (01)04056869299273(21)212023, (01)04056869299273(21)212056, (01)04056869299273(21)212054, (01)04056869299273(21)212063, (01)04056869299273(21)212051, (01)04056869299273(21)212055, (01)04056869299273(21)212021, (01)04056869299273(21)212060, (01)04056869299273(21)212011, (01)04056869299273(21)212066, (01)04056869299273(21)212074, (01)04056869299273(21)212090, (01)04056869299273(21)212034, (01)04056869299273(21)212029, (01)04056869299273(21)212097, (01)04056869299273(21)212099, (01)04056869299273(21)212039, (01)04056869299273(21)212059, (01)04056869299273(21)212030, (01)04056869299273(21)212035, (01)04056869299273(21)212036. Serial Numbers: 212087, 212098, 212088, 212068, 212081, 212018, 212041, 212038, 212047, 212019, 212037, 212032, 212049, 212017, 212064, 212096, 212065, 212016, 212023, 212056, 212054, 212063, 212051, 212055, 212021, 212060, 212011, 212066, 212074, 212090, 212034, 212029, 212097, 212099, 212039, 212059, 212030, 212035, 212036.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Siemens Medical Solutions USA, Inc
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

Product Codes/Lot Numbers:

Model Number: 11516217. UDI Numbers: (01)04056869299273(21)212087, (01)04056869299273(21)212098, (01)04056869299273(21)212088, (01)04056869299273(21)212068, (01)04056869299273(21)212081, (01)04056869299273(21)212018, (01)04056869299273(21)212041, (01)04056869299273(21)212038, (01)04056869299273(21)212047, (01)04056869299273(21)212019, (01)04056869299273(21)212037, (01)04056869299273(21)212032, (01)04056869299273(21)212049, (01)04056869299273(21)212017, (01)04056869299273(21)212064, (01)04056869299273(21)212096, (01)04056869299273(21)212065, (01)04056869299273(21)212016, (01)04056869299273(21)212023, (01)04056869299273(21)212056, (01)04056869299273(21)212054, (01)04056869299273(21)212063, (01)04056869299273(21)212051, (01)04056869299273(21)212055, (01)04056869299273(21)212021, (01)04056869299273(21)212060, (01)04056869299273(21)212011, (01)04056869299273(21)212066, (01)04056869299273(21)212074, (01)04056869299273(21)212090, (01)04056869299273(21)212034, (01)04056869299273(21)212029, (01)04056869299273(21)212097, (01)04056869299273(21)212099, (01)04056869299273(21)212039, (01)04056869299273(21)212059, (01)04056869299273(21)212030, (01)04056869299273(21)212035, (01)04056869299273(21)212036. Serial Numbers: 212087, 212098, 212088, 212068, 212081, 212018, 212041, 212038, 212047, 212019, 212037, 212032, 212049, 212017, 212064, 212096, 212065, 212016, 212023, 212056, 212054, 212063, 212051, 212055, 212021, 212060, 212011, 212066, 212074, 212090, 212034, 212029, 212097, 212099, 212039, 212059, 212030, 212035, 212036.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2662-2025

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