Z-1897-2019 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

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
29

Product Description

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

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: 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