Z-0807-2020 Class II Terminated
FDA device recall Z-0807-2020 was initiated by Siemens Medical Solutions USA, Inc on December 20, 2019 and is designated Class II. 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. The recall status is terminated (terminated May 1, 2020). Affected quantity: 6.
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2020
- Initiation Date
- December 20, 2019
- Termination Date
- May 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
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.
Distribution Pattern
US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.
Code Information
Serial Numbers 164231, 164234, 164240, 164241, 164242, 164244