Z-1903-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2019
- Initiation Date
- June 6, 2019
- Termination Date
- February 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15
Product Description
Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354
Reason for Recall
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
Distribution Pattern
Nationwide
Code Information
Serial Numbers: 111005 111000 111002 111125 111123 111109 111128 111124 111122 111104 111106 111121 111127 111137 111135