Z-0508-2018 Class II Terminated
FDA device recall Z-0508-2018 was initiated by Siemens Medical Solutions USA, Inc on August 24, 2017 and is designated Class II. Reason for recall: Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standa… The recall status is terminated (terminated August 29, 2018). Affected quantity: 265 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- August 24, 2017
- Termination Date
- August 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 265 units
Product Description
AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: 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.
Reason for Recall
Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standards. A quality inspection will be initiated to ensure all screws in the rotation unit meet quality standards.
Distribution Pattern
US Nationwide Distribution
Code Information
10094141 10848282 10848355