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Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a ...

FDA Device Recall #Z-3094-2017 — Class II — February 18, 2016

Recall Summary

Recall Number Z-3094-2017
Classification Class II — Moderate risk
Date Initiated February 18, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 986 units in USA

Product Description

Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

Reason for Recall

Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.

Distribution Pattern

Nationwide Distribution

Lot / Code Information

Artis zee ceiling - Serial number: 146996 147100 147233 147049 147678 147763 147803 147885 147084 147190 147189 147573 147889 146993 147909 147833 147847 147888 146965 147273 147761 147030 147239 147783 147891 146988 147677 147882 147562 147608 146980 147036 147581 147857 125001 147604 147371 147899 147129 147210 147923 147760 147636 147081 147267 147047 147679 147667 125002 147685 125011 147042 147630 147835 147208 147247 147096 147912 147515 147236 147175 146972 147841 147078 147924 147023 147910 147934 147921 147919 147255 147249 147514 147954 147918 147165 147188 147926 147928 147925 147558 146968 147956 147958 147957 147955 147304 147944 147024 147724 125005 147172 147585 147553 147736 147645 147906 147164 147974 147087 147972 146856 146921 147938 125006 147193 147196 147025 147583 147852 147044 147814 147203 147601 147659 147894 147675 147098 147905 147113 147516 147107 147700 147167 147702 147935 147500 147121 147969 147745 147898 147936 147106 147850 147681 147795 147845 146855 146957 147652 147773 147243 125010 147827 147789 147878 147877 147541 147831 147124 147119 147120 147144 147237 147240 147709 147577 147896 147268 147168 147029 125004 147587 147285 147612 147880 147526 147625 147635 146987 146983 146975 147296 147171 147695 146971 146969 146973 147200 147733 147059 147177 147238 147692 147693 147753 147241 147089 146919 147821 147009 147648 147114 147216 147866 147214 146963 147373 147123 147762 147174 147668 147083 147755 147673 147887 147800 146964 147816 147815 147561 147155 147939 147771 147665 147657 146991 146857 147867 147871 147813 147088 147660 147649 147093 147264 147364 125003 147075 147775 147790 125000 147781 147839 147862 147655 147734 147900 147079 147643 147748 146960 147027 147559 147620 146982 147715 147287 147507 147838 147749 147633 147881 147737 147621 147205 147250 147254 147253 147252 147251 125008 147893 147676 147717 147778 147952 147931 147933 146929 146925 147927 147799 147365 147157 147892 147662 146927 147207 147646 147670 147234 147552 147295 147046 147644 147701 147666 147557 147661 147307 147766 147971 147718 147917 147103 147303 147849 147842 147265 147301 147235 147094 147716 147739 147743 147752 147937 147031 147746 147528 147656 147940 146977 147687 147109 147863 147186

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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