Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 50135 50131 50171 50129 50048 50184 50180 50136 50185 50153 50155 50130 50127 50134 50166 50192 50161 50128 50132 50160
  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:
The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194

Product Codes/Lot Numbers:

Serial Numbers: 50135 50131 50171 50129 50048 50184 50180 50136 50185 50153 50155 50130 50127 50134 50166 50192 50161 50128 50132 50160

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2128-2020

Related Recalls

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 →
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 →