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Artis zee floor, Model Number 10094135

FDA Device Recall #Z-2028-2019 — Class II — June 12, 2019

Recall Summary

Recall Number Z-2028-2019
Classification Class II — Moderate risk
Date Initiated June 12, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 170

Product Description

Artis zee floor, Model Number 10094135

Reason for Recall

A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

Serial Numbers: 135944 135746 135120 135322 135757 136513 136562 135914 135102 136042 135927 135986 135935 135953 135841 135200 135201 135279 135169 135879 135229 135157 136113 135990 136077 136103 135862 135235 135117 135358 135920 136168 135148 135366 136568 135843 135111 135112 135779 136224 135137 136607 136579 135309 124007 124015 136280 136286 135109 135413 135144 135145 136362 135404 136318 136234 135151 135421 135264 135199 135760 136500 136515 135217 136031 136032 135124 135125 136084 136026 136479 135179 135394 135285 136338 136196 135245 135420 136384 136387 136488 135770 136550 136256 136408 136450 136508 136547 135788 136242 136383 136517 135406 136043 136586 135129 135416 135909 135222 136393 136520 135258 135260 135755 136548 135143 135114 135133 136350 135353 135253 135375 135772 136483 136555 135190 135881 136614 137384 136567 135714 135922 136314 136190 136197 136254 135813 135791 136561 135302 135152 136505 135182 124006 135868 135793 135132 135723 136126 135847 135281 135373 135196 136128 136147 136557 136558 136391 136503 136143 135352 135388 135384 136582 136345 136570 135954 136459 136518 135771 136290 136609 135233 136594 135203 136137 135286 135397 136278 135424

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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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