Z-1897-2019 Class II Terminated
FDA device recall Z-1897-2019 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: 29.
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