FDA Enforcement
Class II
Terminated
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.
Recall: Z-0508-2018
·
Reported February 14, 2018
Enforcement
- Recall Number
- Z-0508-2018
- Event ID
- 79039
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 14, 2018
- Initiation Date
- August 24, 2017
- Classification Date
- February 2, 2018
- Termination Date
- August 29, 2018
- Address
- 40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States
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
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.
Code Info
10094141 10848282 10848355
Distribution
US Nationwide Distribution
Quantity
265 units