Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Artis zeego systems with Artis patient table and AppSW VD20C/VD20N
  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:
Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815

Product Codes/Lot Numbers:

Artis zeego systems with Artis patient table and AppSW VD20C/VD20N

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0200-2022

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