FDA recall Z-0807-2020

Siemens Medical Solutions USA, Inc · Class II · device

Product

Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Reason for recall

The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.

Distribution

US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.

Key facts

Status
Terminated
Initiation date
2019-12-20
Report date
2020-01-22
Termination date
2020-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0807-2020