🔍 RecallPedia

MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

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: 10684334. UDI Numbers: (01)04056869006680(21)162012, (01)04056869006680(21)162055, (01)04056869006680(21)162039, (01)04056869006680(21)162002, (01)04056869006680(21)162014, (01)04056869006680(21)162069, (01)04056869006680(21)162083, (01)04056869006680(21)162075, (01)04056869006680(21)162028, (01)04056869006680(21)162060, (01)04056869006680(21)162035, (01)04056869006680(21)162038, (01)04056869006680(21)162016, (01)04056869006680(21)62040, (01)04056869006680(21)162036, (01)04056869006680(21)162079, (01)04056869006680(21)162054, (01)04056869006680(21)162088, (01)04056869006680(21)162071, (01)04056869006680(21)162078, (01)04056869006680(21)62032, (01)04056869006680(21)62037, (01)04056869006680(21)162077, (01)04056869006680(21)162042, (01)04056869006680(21)162025, (01)04056869006680(21)162082, (01)04056869006680(21)162085, (01)04056869006680(21)162026, (01)04056869006680(21)62027, (01)04056869006680(21)162040, (01)04056869006680(21)162032, (01)04056869006680(21)162072, (01)04056869006680(21)162037, (01)04056869006680(21)162043, (01)04056869006680(21)62014, (01)04056869006680(21)162047, (01)04056869006680(21)162023, (01)04056869006680(21)62019, (01)04056869006680(21)62050, (01)04056869006680(21)162089, (01)04056869006680(21)162061, (01)04056869006680(21)62018, (01)04056869006680(21)162004, (01)04056869006680(21)162080, (01)04056869006680(21)162013, (01)04056869006680(21)162007, (01)04056869006680(21)162049, (01)04056869006680(21)162031, (01)04056869006680(21)162009, (01)04056869006680(21)162008, (01)04056869006680(21)62029, (01)04056869006680(21)162056, (01)04056869006680(21)62025, (01)04056869006680(21)62022, (01)04056869006680(21)162048, (01)04056869006680(21)62036, (01)04056869006680(21)162087, (01)04056869006680(21)162081, (01)04056869006680(21)162073, (01)04056869006680(21)162044, (01)04056869006680(21)162076, (01)04056869006680(21)162003, (01)04056869006680(21)162006, (01)04056869006680(21)62023, (01)04056869006680(21)162021, (01)04056869006680(21)162074, (01)04056869006680(21)162017, (01)04056869006680(21)162029, (01)04056869006680(21)162022, (01)04056869006680(21)62035, (01)04056869006680(21)162065, (01)04056869006680(21)62039, (01)04056869006680(21)162034, (01)04056869006680(21)162001, (01)04056869006680(21)162018, (01)04056869006680(21)62042, (01)04056869006680(21)162086, (01)04056869006680(21)162011. Serial Numbers: 162012, 162055, 162039, 162002, 162014, 162069, 162083, 162075, 162028, 162060, 162035, 162038, 162016, 62040, 162036, 162079, 162054, 162088, 162071, 162078, 62032, 62037, 162077, 162042, 162025, 162082, 162085, 162026, 62027, 162040, 162032, 162072, 162037, 162043, 62014, 162047, 162023, 62019, 62050, 162089, 162061, 62018, 162004, 162080, 162013, 162007, 162049, 162031, 162009, 162008, 62029, 162056, 62025, 62022, 162048, 62036, 162087, 162081, 162073, 162044, 162076, 162003, 162006, 62023, 162021, 162074, 162017, 162029, 162022, 62035, 162065, 62039, 162034, 162001, 162018, 62042, 162086, 162011.
  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 Upgrade. Model Number: 10684334.

Product Codes/Lot Numbers:

Model Number: 10684334. UDI Numbers: (01)04056869006680(21)162012, (01)04056869006680(21)162055, (01)04056869006680(21)162039, (01)04056869006680(21)162002, (01)04056869006680(21)162014, (01)04056869006680(21)162069, (01)04056869006680(21)162083, (01)04056869006680(21)162075, (01)04056869006680(21)162028, (01)04056869006680(21)162060, (01)04056869006680(21)162035, (01)04056869006680(21)162038, (01)04056869006680(21)162016, (01)04056869006680(21)62040, (01)04056869006680(21)162036, (01)04056869006680(21)162079, (01)04056869006680(21)162054, (01)04056869006680(21)162088, (01)04056869006680(21)162071, (01)04056869006680(21)162078, (01)04056869006680(21)62032, (01)04056869006680(21)62037, (01)04056869006680(21)162077, (01)04056869006680(21)162042, (01)04056869006680(21)162025, (01)04056869006680(21)162082, (01)04056869006680(21)162085, (01)04056869006680(21)162026, (01)04056869006680(21)62027, (01)04056869006680(21)162040, (01)04056869006680(21)162032, (01)04056869006680(21)162072, (01)04056869006680(21)162037, (01)04056869006680(21)162043, (01)04056869006680(21)62014, (01)04056869006680(21)162047, (01)04056869006680(21)162023, (01)04056869006680(21)62019, (01)04056869006680(21)62050, (01)04056869006680(21)162089, (01)04056869006680(21)162061, (01)04056869006680(21)62018, (01)04056869006680(21)162004, (01)04056869006680(21)162080, (01)04056869006680(21)162013, (01)04056869006680(21)162007, (01)04056869006680(21)162049, (01)04056869006680(21)162031, (01)04056869006680(21)162009, (01)04056869006680(21)162008, (01)04056869006680(21)62029, (01)04056869006680(21)162056, (01)04056869006680(21)62025, (01)04056869006680(21)62022, (01)04056869006680(21)162048, (01)04056869006680(21)62036, (01)04056869006680(21)162087, (01)04056869006680(21)162081, (01)04056869006680(21)162073, (01)04056869006680(21)162044, (01)04056869006680(21)162076, (01)04056869006680(21)162003, (01)04056869006680(21)162006, (01)04056869006680(21)62023, (01)04056869006680(21)162021, (01)04056869006680(21)162074, (01)04056869006680(21)162017, (01)04056869006680(21)162029, (01)04056869006680(21)162022, (01)04056869006680(21)62035, (01)04056869006680(21)162065, (01)04056869006680(21)62039, (01)04056869006680(21)162034, (01)04056869006680(21)162001, (01)04056869006680(21)162018, (01)04056869006680(21)62042, (01)04056869006680(21)162086, (01)04056869006680(21)162011. Serial Numbers: 162012, 162055, 162039, 162002, 162014, 162069, 162083, 162075, 162028, 162060, 162035, 162038, 162016, 62040, 162036, 162079, 162054, 162088, 162071, 162078, 62032, 62037, 162077, 162042, 162025, 162082, 162085, 162026, 62027, 162040, 162032, 162072, 162037, 162043, 62014, 162047, 162023, 62019, 62050, 162089, 162061, 62018, 162004, 162080, 162013, 162007, 162049, 162031, 162009, 162008, 62029, 162056, 62025, 62022, 162048, 62036, 162087, 162081, 162073, 162044, 162076, 162003, 162006, 62023, 162021, 162074, 162017, 162029, 162022, 62035, 162065, 62039, 162034, 162001, 162018, 62042, 162086, 162011.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2666-2025

Related Recalls

ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system

Siemens Medical Solutions USA

Class I - Dangerous

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

Mar 9, 2026 Other Medical Devices View Details →

ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

Siemens Medical Solutions USA

Class I - Dangerous

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

Mar 9, 2026 Other Medical Devices View Details →

ARTIS Pheno VE30A and VE40A, Model 10849000

Siemens Medical Solutions USA

Class I - Dangerous

During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

Mar 12, 2026 Other Medical Devices View Details →