Z-1902-2019 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
8

Product Description

Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353

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: 105018 105016 105032 105124 105119 105123 105121 105122