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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-3092-2017 — Class II — February 18, 2016

Recall Summary

Recall Number Z-3092-2017
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 biplane- Serial number: 154502 154616 154536 154096 154454 154715 154789 154779 154532 131017 154157 154722 154721 154571 154074 154612 154090 154658 154686 154095 154567 154480 154093 154086 154704 153882 154727 154408 154509 154079 154462 154098 154073 154076 154792 154156 154799 154814 154783 154731 154683 153878 154565 154653 154671 154556 154406 154518 154778 154685 137650 131005 154633 154020 154058 154155 153884 154453 154708 154579 154762 154034 154018 154560 154596 154066 154663 154544 154614 154048 154800 154592 154684 154087 154085 154471 154606 154604 154456 154687 154707 154459 131000 154581 154423 154546 154052 154028 154084 154732 154709 154678 131011 154430 154501 154514 154075 154064 154562 154585 154044 154770 154035 154056 154785 154425 154082 154429 154055 154631 154476 154088 154067 154584 154610 154094 154576 154089 154041 154739 154077 154602 154097 154615 154572 154564

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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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