🔍 RecallPedia

MAGNETOM Prisma. Model Number: 10849582.

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: 10849582. UDI Numbers: (01)04056869006727(21)166324, (01)04056869006727(21)66104, (01)04056869006727(21)166097, (01)04056869006727(21)166024, (01)04056869006727(21)166018, (01)04056869006727(21)66109, (01)04056869006727(21)66111, (01)04056869006727(21)166114, (01)04056869006727(21)166242, (01)04056869006727(21)166268, (01)04056869006727(21)166200, (01)04056869006727(21)166047, (01)04056869006727(21)66047, (01)04056869006727(21)166292, (01)04056869006727(21)166041, (01)04056869006727(21)166007, (01)04056869006727(21)166037, (01)04056869006727(21)66112, (01)04056869006727(21)166025, (01)04056869006727(21)166003, (01)04056869006727(21)66102, (01)04056869006727(21)166254, (01)04056869006727(21)166074, (01)04056869006727(21)166281, (01)04056869006727(21)166220, (01)04056869006727(21)66027, (01)04056869006727(21)166221, (01)04056869006727(21)166321, (01)04056869006727(21)166193, (01)04056869006727(21)166012, (01)04056869006727(21)166121, (01)04056869006727(21)66053, (01)04056869006727(21)166160, (01)04056869006727(21)66094, (01)04056869006727(21)166310, (01)04056869006727(21)66028, (01)04056869006727(21)166102, (01)04056869006727(21)166034, (01)04056869006727(21)166030, (01)04056869006727(21)66106, (01)04056869006727(21)166235, (01)04056869006727(21)166273, (01)04056869006727(21)166201, (01)04056869006727(21)166345, (01)04056869006727(21)166225, (01)04056869006727(21)66044, (01)04056869006727(21)66018, (01)04056869006727(21)166006, (01)04056869006727(21)166009, (01)04056869006727(21)166295, (01)04056869006727(21)166227, (01)04056869006727(21)166188, (01)04056869006727(21)166046, (01)04056869006727(21)166296, (01)04056869006727(21)166298, (01)04056869006727(21)66022, (01)04056869006727(21)66057, (01)04056869006727(21)166326, (01)04056869006727(21)166327, (01)04056869006727(21)166048, (01)04056869006727(21)166289, (01)04056869006727(21)166049, (01)04056869006727(21)66069, (01)04056869006727(21)166040, (01)04056869006727(21)166039, (01)04056869006727(21)166017, (01)04056869006727(21)66092, (01)04056869006727(21)66105, (01)04056869006727(21)166224, (01)04056869006727(21)166319, (01)04056869006727(21)166014, (01)04056869006727(21)166239, (01)04056869006727(21)66046, (01)04056869006727(21)66082, (01)04056869006727(21)166362, (01)04056869006727(21)166179, (01)04056869006727(21)166019, (01)04056869006727(21)166311, (01)04056869006727(21)166330, (01)04056869006727(21)166133, (01)04056869006727(21)166210, (01)04056869006727(21)166285, (01)04056869006727(21)166162, (01)04056869006727(21)66096, (01)04056869006727(21)166082, (01)04056869006727(21)166083, (01)04056869006727(21)66059, (01)04056869006727(21)166084, (01)04056869006727(21)166250, (01)04056869006727(21)166023, (01)04056869006727(21)166272, (01)04056869006727(21)166090, (01)04056869006727(21)166038, (01)04056869006727(21)166158, (01)04056869006727(21)166315, (01)04056869006727(21)166091, (01)04056869006727(21)166313, (01)04056869006727(21)166307, (01)04056869006727(21)166033, (01)04056869006727(21)166010, (01)04056869006727(21)166011. Serial Numbers: 166324, 66104, 166097, 166024, 166018, 66109, 66111, 166114, 166242, 166268, 166200, 166047, 66047, 166292, 166041, 166007, 166037, 66112, 166025, 166003, 66102, 166254, 166074, 166281, 166220, 66027, 166221, 166321, 166193, 166012, 166121, 66053, 166160, 66094, 166310, 66028, 166102, 166034, 166030, 66106, 166235, 166273, 166201, 166345, 166225, 66044, 66018, 166006, 166009, 166295, 166227, 166188, 166046, 166296, 166298, 66022, 66057, 166326, 166327, 166048, 166289, 166049, 66069, 166040, 166039, 166017, 66092, 66105, 166224, 166319, 166014, 166239, 66046, 66082, 166362, 166179, 166019, 166311, 166330, 166133, 166210, 166285, 166162, 66096, 166082, 166083, 66059, 166084, 166250, 166023, 166272, 166090, 166038, 166158, 166315, 166091, 166313, 166307, 166033, 166010, 166011.
  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 Prisma. Model Number: 10849582.

Product Codes/Lot Numbers:

Model Number: 10849582. UDI Numbers: (01)04056869006727(21)166324, (01)04056869006727(21)66104, (01)04056869006727(21)166097, (01)04056869006727(21)166024, (01)04056869006727(21)166018, (01)04056869006727(21)66109, (01)04056869006727(21)66111, (01)04056869006727(21)166114, (01)04056869006727(21)166242, (01)04056869006727(21)166268, (01)04056869006727(21)166200, (01)04056869006727(21)166047, (01)04056869006727(21)66047, (01)04056869006727(21)166292, (01)04056869006727(21)166041, (01)04056869006727(21)166007, (01)04056869006727(21)166037, (01)04056869006727(21)66112, (01)04056869006727(21)166025, (01)04056869006727(21)166003, (01)04056869006727(21)66102, (01)04056869006727(21)166254, (01)04056869006727(21)166074, (01)04056869006727(21)166281, (01)04056869006727(21)166220, (01)04056869006727(21)66027, (01)04056869006727(21)166221, (01)04056869006727(21)166321, (01)04056869006727(21)166193, (01)04056869006727(21)166012, (01)04056869006727(21)166121, (01)04056869006727(21)66053, (01)04056869006727(21)166160, (01)04056869006727(21)66094, (01)04056869006727(21)166310, (01)04056869006727(21)66028, (01)04056869006727(21)166102, (01)04056869006727(21)166034, (01)04056869006727(21)166030, (01)04056869006727(21)66106, (01)04056869006727(21)166235, (01)04056869006727(21)166273, (01)04056869006727(21)166201, (01)04056869006727(21)166345, (01)04056869006727(21)166225, (01)04056869006727(21)66044, (01)04056869006727(21)66018, (01)04056869006727(21)166006, (01)04056869006727(21)166009, (01)04056869006727(21)166295, (01)04056869006727(21)166227, (01)04056869006727(21)166188, (01)04056869006727(21)166046, (01)04056869006727(21)166296, (01)04056869006727(21)166298, (01)04056869006727(21)66022, (01)04056869006727(21)66057, (01)04056869006727(21)166326, (01)04056869006727(21)166327, (01)04056869006727(21)166048, (01)04056869006727(21)166289, (01)04056869006727(21)166049, (01)04056869006727(21)66069, (01)04056869006727(21)166040, (01)04056869006727(21)166039, (01)04056869006727(21)166017, (01)04056869006727(21)66092, (01)04056869006727(21)66105, (01)04056869006727(21)166224, (01)04056869006727(21)166319, (01)04056869006727(21)166014, (01)04056869006727(21)166239, (01)04056869006727(21)66046, (01)04056869006727(21)66082, (01)04056869006727(21)166362, (01)04056869006727(21)166179, (01)04056869006727(21)166019, (01)04056869006727(21)166311, (01)04056869006727(21)166330, (01)04056869006727(21)166133, (01)04056869006727(21)166210, (01)04056869006727(21)166285, (01)04056869006727(21)166162, (01)04056869006727(21)66096, (01)04056869006727(21)166082, (01)04056869006727(21)166083, (01)04056869006727(21)66059, (01)04056869006727(21)166084, (01)04056869006727(21)166250, (01)04056869006727(21)166023, (01)04056869006727(21)166272, (01)04056869006727(21)166090, (01)04056869006727(21)166038, (01)04056869006727(21)166158, (01)04056869006727(21)166315, (01)04056869006727(21)166091, (01)04056869006727(21)166313, (01)04056869006727(21)166307, (01)04056869006727(21)166033, (01)04056869006727(21)166010, (01)04056869006727(21)166011. Serial Numbers: 166324, 66104, 166097, 166024, 166018, 66109, 66111, 166114, 166242, 166268, 166200, 166047, 66047, 166292, 166041, 166007, 166037, 66112, 166025, 166003, 66102, 166254, 166074, 166281, 166220, 66027, 166221, 166321, 166193, 166012, 166121, 66053, 166160, 66094, 166310, 66028, 166102, 166034, 166030, 66106, 166235, 166273, 166201, 166345, 166225, 66044, 66018, 166006, 166009, 166295, 166227, 166188, 166046, 166296, 166298, 66022, 66057, 166326, 166327, 166048, 166289, 166049, 66069, 166040, 166039, 166017, 66092, 66105, 166224, 166319, 166014, 166239, 66046, 66082, 166362, 166179, 166019, 166311, 166330, 166133, 166210, 166285, 166162, 66096, 166082, 166083, 66059, 166084, 166250, 166023, 166272, 166090, 166038, 166158, 166315, 166091, 166313, 166307, 166033, 166010, 166011.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2659-2025

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