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.
Reported: January 22, 2020 Initiated: December 20, 2019 #Z-0807-2020
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 6
- Distribution
- US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 6.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2020. Severity: Moderate. Recall number: Z-0807-2020.
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