Z-1340-2020 Class II Terminated
FDA device recall Z-1340-2020 was initiated by Siemens Medical Solutions USA, Inc on January 24, 2020 and is designated Class II. Reason for recall: Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the … The recall status is terminated (terminated July 10, 2020). Affected quantity: 96 US.
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- January 24, 2020
- Termination Date
- July 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96 US
Product Description
ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Axiom Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
Reason for Recall
Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements
Distribution Pattern
US Nationwide distribution.
Code Information
All serial numbers