FDA recall Z-1902-2019

Product

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

Nationwide

Key facts

Status

Terminated

Initiation date

2019-06-06

Report date

2019-07-10

Termination date

2021-02-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1902-2019