Home / Recalls / Siemens Medical Solutions USA, Inc / Z-3190-2018

Z-3190-2018 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-3190-2018 was initiated by Siemens Medical Solutions USA, Inc on Jul 29, 2018 and is designated Class II. 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… The recall status is terminated (terminated May 17, 2019). Affected quantity: 429 total.

Recall Details

Product Type: Devices
Report Date: Sep 26, 2018
Initiation Date: Jul 29, 2018
Termination Date: May 17, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 429 total

Product Description

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 Pattern

US nationwide distribution.

Code Information

164013 164011

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-3190-2018
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.