🔍 RecallPedia

MAGNETOM Skyra fit. Model Number: 10849580.

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: 10849580. UDI Numbers: (01)04056869006710(21)170068, (01)04056869006710(21)170053, (01)04056869006710(21)70022, (01)04056869006710(21)170049, (01)04056869006710(21)170018, (01)04056869006680(21)162078, (01)04056869006710(21)170109, (01)04056869006710(21)170039, (01)04056869006710(21)170066, (01)04056869006710(21)170023, (01)04056869006710(21)170030, (01)04056869006710(21)170004, (01)04056869006710(21)170016, (01)04056869006710(21)170077, (01)04056869006710(21)170058, (01)04056869006710(21)170002, (01)04056869006710(21)170050, (01)04056869006710(21)170010, (01)04056869006710(21)170019, (01)04056869006710(21)70026, (01)04056869006710(21)170056, (01)04056869006710(21)170061, (01)04056869006710(21)170105, (01)04056869006710(21)170017, (01)04056869006710(21)170041, (01)04056869006710(21)70032, (01)04056869006710(21)170111, (01)04056869006710(21)170048, (01)04056869006710(21)170101, (01)04056869006710(21)170100, (01)04056869006710(21)170060, (01)04056869006710(21)170099, (01)04056869006710(21)170036, (01)04056869006710(21)170007, (01)04056869006710(21)170001, (01)04056869006710(21)170009, (01)04056869006710(21)70020, (01)04056869006710(21)170112, (01)04056869006710(21)170113, (01)04056869006710(21)170054, (01)04056869006710(21)170047, (01)04056869006710(21)170046, (01)04056869006710(21)70023, (01)04056869006710(21)70027, (01)04056869006710(21)170110, (01)04056869006710(21)170095, (01)04056869006710(21)170075, (01)04056869006710(21)170011, (01)04056869006710(21)170081, (01)04056869006710(21)170044, (01)04056869006710(21)70028, (01)04056869006710(21)170043, (01)04056869006710(21)70031, (01)04056869006710(21)70008. Serial Numbers: 170068, 170053, 70022, 170049, 170018, 170106, 170109, 170039, 170066, 170023, 170030, 170004, 170016, 170077, 170058, 170002, 170050, 170010, 170019, 70026, 170056, 170061, 170105, 170017, 170041, 70032, 170111, 170048, 170101, 170100, 170060, 170099, 170036, 170007, 170001, 170009, 70020, 170112, 170113, 170054, 170047, 170046, 70023, 70027, 170110, 170095, 170075, 170011, 170081, 170044, 70028, 170043, 70031, 70008.
  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. Model Number: 10849580.

Product Codes/Lot Numbers:

Model Number: 10849580. UDI Numbers: (01)04056869006710(21)170068, (01)04056869006710(21)170053, (01)04056869006710(21)70022, (01)04056869006710(21)170049, (01)04056869006710(21)170018, (01)04056869006680(21)162078, (01)04056869006710(21)170109, (01)04056869006710(21)170039, (01)04056869006710(21)170066, (01)04056869006710(21)170023, (01)04056869006710(21)170030, (01)04056869006710(21)170004, (01)04056869006710(21)170016, (01)04056869006710(21)170077, (01)04056869006710(21)170058, (01)04056869006710(21)170002, (01)04056869006710(21)170050, (01)04056869006710(21)170010, (01)04056869006710(21)170019, (01)04056869006710(21)70026, (01)04056869006710(21)170056, (01)04056869006710(21)170061, (01)04056869006710(21)170105, (01)04056869006710(21)170017, (01)04056869006710(21)170041, (01)04056869006710(21)70032, (01)04056869006710(21)170111, (01)04056869006710(21)170048, (01)04056869006710(21)170101, (01)04056869006710(21)170100, (01)04056869006710(21)170060, (01)04056869006710(21)170099, (01)04056869006710(21)170036, (01)04056869006710(21)170007, (01)04056869006710(21)170001, (01)04056869006710(21)170009, (01)04056869006710(21)70020, (01)04056869006710(21)170112, (01)04056869006710(21)170113, (01)04056869006710(21)170054, (01)04056869006710(21)170047, (01)04056869006710(21)170046, (01)04056869006710(21)70023, (01)04056869006710(21)70027, (01)04056869006710(21)170110, (01)04056869006710(21)170095, (01)04056869006710(21)170075, (01)04056869006710(21)170011, (01)04056869006710(21)170081, (01)04056869006710(21)170044, (01)04056869006710(21)70028, (01)04056869006710(21)170043, (01)04056869006710(21)70031, (01)04056869006710(21)70008. Serial Numbers: 170068, 170053, 70022, 170049, 170018, 170106, 170109, 170039, 170066, 170023, 170030, 170004, 170016, 170077, 170058, 170002, 170050, 170010, 170019, 70026, 170056, 170061, 170105, 170017, 170041, 70032, 170111, 170048, 170101, 170100, 170060, 170099, 170036, 170007, 170001, 170009, 70020, 170112, 170113, 170054, 170047, 170046, 70023, 70027, 170110, 170095, 170075, 170011, 170081, 170044, 70028, 170043, 70031, 70008.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2661-2025

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