FDA Recall
Terminated
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.
Recall: Z-0807-2020
·
Initiated December 20, 2019
Recall
- Recall Number
- Z-0807-2020
- Event Number
- 84648
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- OWB
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- December 20, 2019
- Terminated
- May 1, 2020
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418
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
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.
Action
Siemens Medical Solutions USA, Inc. sent a Customer Safety Advisory Notice to all affected customers via AX070/19/S on 12/20/2019.
Distribution
US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.
Quantity
6