Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 82010 82038 82039 82040 82044 82054 82065 82066 82070 82102 82105 82108 82109 82205 82213 82217 82267 82308 82354 82355 82378 82383
  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:
Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.

Product Codes/Lot Numbers:

Serial Numbers: 82010 82038 82039 82040 82044 82054 82065 82066 82070 82102 82105 82108 82109 82205 82213 82217 82267 82308 82354 82355 82378 82383

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0298-2021

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