Z-0614-2018 Class II Terminated
FDA device recall Z-0614-2018 was initiated by Siemens Medical Solutions USA, INC on August 22, 2017 and is designated Class II. Reason for recall: The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen The recall status is terminated (terminated August 21, 2018). Affected quantity: 207 worldwide (13 distributed in US).
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- August 22, 2017
- Termination Date
- August 21, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 207 worldwide (13 distributed in US)
Product Description
Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus
Reason for Recall
The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen
Distribution Pattern
US Distribution to the states of : AR, MO, NY, IN, AR, TX , NC, PA, MI, LA, WA, CA and AL.
Code Information
Serial # 82044; 82105; 82070; 82054; 82040;82038;82065 82108; 82010; 82039; 82109 82102 82066