Device product
Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000
Z-1905-2019
Product summary
- Event
- Event 83082
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8
- Official record key
device-enforcement:Z-1905-2019
Official wording
Reason: 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
Code information: Serial Numbers: 164021 164053 164055 164054 164088 164140 164113 164069
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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