Device product
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.
Z-0807-2020
Product summary
- Event
- Event 84648
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6
- Official record key
device-enforcement:Z-0807-2020
Official wording
Reason: 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.
Code information: Serial Numbers 164231, 164234, 164240, 164241, 164242, 164244
Distribution pattern: US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.
Derived failure modes
-
Unknown
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.