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Recall Observatory FDA recall evidence

Device product

Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000

Z-1905-2019

June 06, 2019

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
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

    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