FDAFDA · Food and drugs·Recall number Z-0807-2020
Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Published January 22, 2020 · Recall initiated: December 20, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.
- Lot
- Serial Numbers 164231, 164234, 164240, 164241, 164242, 164244
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States