FDA recall Z-3190-2018

Siemens Medical Solutions USA, Inc · Class II · device

Product

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000

Reason for recall

Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).

Distribution

US nationwide distribution.

Key facts

Status: Terminated
Initiation date: 2018-07-29
Report date: 2018-09-26
Termination date: 2019-05-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3190-2018