🔍 RecallPedia

MAGNETOM Verio Dot. Model Number: 10684333.

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: 10684333. UDI Numbers: (01)04056869006673(21)60060, (01)04056869006673(21)160040, (01)04056869006673(21)160028, (01)04056869006673(21)160021, (01)04056869006673(21)60108, (01)04056869006673(21)60121, (01)04056869006673(21)160019, (01)04056869006673(21)60091, (01)04056869006673(21)160020, (01)04056869006673(21)160043, (01)04056869006673(21)60062, (01)04056869006673(21)60061, (01)04056869006673(21)160029, (01)04056869006673(21)160038, (01)04056869006673(21)60086, (01)04056869006673(21)60126, (01)04056869006673(21)60047, (01)04056869006673(21)160036, (01)04056869006673(21)160003, (01)04056869006673(21)160042, (01)04056869006673(21)160024, (01)04056869006673(21)60092, (01)04056869006673(21)160035, (01)04056869006673(21)60102, (01)04056869006673(21)160039, (01)04056869006673(21)60112, (01)04056869006673(21)160030, (01)04056869006673(21)60099, (01)04056869006673(21)160007, (01)04056869006673(21)160001, (01)04056869006673(21)160006, (01)04056869006673(21)160009, (01)04056869006673(21)160033, (01)04056869006673(21)60053, (01)04056869006673(21)60070, (01)04056869006673(21)60101, (01)04056869006673(21)60125, (01)04056869006673(21)60085, (01)04056869006673(21)60113, (01)04056869006673(21)160027, (01)04056869006673(21)160012, (01)04056869006673(21)160016, (01)04056869006673(21)160032, (01)04056869006673(21)160013, (01)04056869006673(21)160014, (01)04056869006673(21)160018, (01)04056869006673(21)160031, (01)04056869006673(21)160011, (01)04056869006673(21)160015, (01)04056869006673(21)60054, (01)04056869006673(21)160037, (01)04056869006673(21)160034, (01)04056869006673(21)60063, (01)04056869006673(21)60079, (01)04056869006673(21)160008, (01)04056869006673(21)60110, (01)04056869006673(21)60124, (01)04056869006673(21)160041. Serial Numbers: 60060, 160040, 160028, 160021, 60108, 60121, 160019, 60091, 160020, 160043, 60062, 60061, 160029, 160038, 60086, 60126, 60047, 160036, 160003, 160042, 160024, 60092, 160035, 60102, 160039, 60112, 160030, 60099, 160007, 160001, 160006, 160009, 160033, 60053, 60070, 60101, 60125, 60085, 60113, 160027, 160012, 160016, 160032, 160013, 160014, 160018, 160031, 160011, 160015, 60054, 160037, 160034, 60063, 60079, 160008, 60110, 60124, 160041.
  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 Verio Dot. Model Number: 10684333.

Product Codes/Lot Numbers:

Model Number: 10684333. UDI Numbers: (01)04056869006673(21)60060, (01)04056869006673(21)160040, (01)04056869006673(21)160028, (01)04056869006673(21)160021, (01)04056869006673(21)60108, (01)04056869006673(21)60121, (01)04056869006673(21)160019, (01)04056869006673(21)60091, (01)04056869006673(21)160020, (01)04056869006673(21)160043, (01)04056869006673(21)60062, (01)04056869006673(21)60061, (01)04056869006673(21)160029, (01)04056869006673(21)160038, (01)04056869006673(21)60086, (01)04056869006673(21)60126, (01)04056869006673(21)60047, (01)04056869006673(21)160036, (01)04056869006673(21)160003, (01)04056869006673(21)160042, (01)04056869006673(21)160024, (01)04056869006673(21)60092, (01)04056869006673(21)160035, (01)04056869006673(21)60102, (01)04056869006673(21)160039, (01)04056869006673(21)60112, (01)04056869006673(21)160030, (01)04056869006673(21)60099, (01)04056869006673(21)160007, (01)04056869006673(21)160001, (01)04056869006673(21)160006, (01)04056869006673(21)160009, (01)04056869006673(21)160033, (01)04056869006673(21)60053, (01)04056869006673(21)60070, (01)04056869006673(21)60101, (01)04056869006673(21)60125, (01)04056869006673(21)60085, (01)04056869006673(21)60113, (01)04056869006673(21)160027, (01)04056869006673(21)160012, (01)04056869006673(21)160016, (01)04056869006673(21)160032, (01)04056869006673(21)160013, (01)04056869006673(21)160014, (01)04056869006673(21)160018, (01)04056869006673(21)160031, (01)04056869006673(21)160011, (01)04056869006673(21)160015, (01)04056869006673(21)60054, (01)04056869006673(21)160037, (01)04056869006673(21)160034, (01)04056869006673(21)60063, (01)04056869006673(21)60079, (01)04056869006673(21)160008, (01)04056869006673(21)60110, (01)04056869006673(21)60124, (01)04056869006673(21)160041. Serial Numbers: 60060, 160040, 160028, 160021, 60108, 60121, 160019, 60091, 160020, 160043, 60062, 60061, 160029, 160038, 60086, 60126, 60047, 160036, 160003, 160042, 160024, 60092, 160035, 60102, 160039, 60112, 160030, 60099, 160007, 160001, 160006, 160009, 160033, 60053, 60070, 60101, 60125, 60085, 60113, 160027, 160012, 160016, 160032, 160013, 160014, 160018, 160031, 160011, 160015, 60054, 160037, 160034, 60063, 60079, 160008, 60110, 60124, 160041.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2665-2025

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