Artis Zee Angiographic x-ray systems.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959.
  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:
An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Artis Zee Angiographic x-ray systems.

Product Codes/Lot Numbers:

Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959.

Distribution:

Distributed in: MN, WI, PA, MI, AL, OH, NC, AR, NJ

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1309-2014

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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.

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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.

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