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Recall Observatory FDA recall evidence

Device product

Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959

Z-1897-2019

June 06, 2019

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
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

    reason.no_named_rule · v1.0.0

    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