Recall Z-3190-2018— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-07-29, terminated 2019-05-17. It names one FDA 510(k) clearance: K163286. 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)..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-29
- Terminated
- 2019-05-17
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.