FDA Device recall Z-3190-2018
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
- FDA Device
- Class II
- terminated
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class II recall of ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000 by Siemens Medical Solutions Usa, citing 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 o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3190-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-29 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Reason
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).
Identifiers
| code_info | 164013 164011 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3190-2018%22
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