Z-1903-2019 Class II Terminated
FDA device recall Z-1903-2019 was initiated by Siemens Medical Solutions USA, Inc on June 6, 2019 and is designated Class II. 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 th… The recall status is terminated (terminated February 9, 2021). Affected quantity: 15.
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
- 15
Product Description
Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354
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: 111005 111000 111002 111125 111123 111109 111128 111124 111122 111104 111106 111121 111127 111137 111135