Device product
Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
Z-1897-2019
Product summary
- Event
- Event 83082
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29
- Official record key
device-enforcement:Z-1897-2019
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: 160335 160430 160368 160469 160357 160370 160369 160509 160427 160433 160443 160428 160429 160463 160001 160461 160486 160800 160487 160488 160507 160840 160862 160856 160823 160914 160930 161235 160401
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