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Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), ...

FDA Device Recall #Z-0299-2019 — Class II — August 6, 2018

Recall Summary

Recall Number Z-0299-2019
Classification Class II — Moderate risk
Date Initiated August 6, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 142

Product Description

Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.

Reason for Recall

In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock. This could lead to overloading the safety rope, which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning.

Distribution Pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NM, NV, NY, OH, OK, PA, PR, SC, SD, TX, UT, VA, WI, and WY.

Lot / Code Information

Serial Number 23071 22776 23623 23678 22787 23021 22848 22288 22960 23082 22501 23029 23163 23164 23518 23519 22517 23538 23097 22781 23147 22506 22634 22844 23427 23169 23529 22880 23699 22429 23640 22650 22737 22542 22176 22500 22350 22247 22347 22724 22725 22895 22833 22955 22058 23400 22847 22852 22367 22600 23650 23651 22705 22928 22609 23136 23133 23137 23556 22543 23474 22821 23517 23118 23410 22789 22208 22632 23022 23024 23132 23663 23149 22743 22851 22175 23602 23018 23019 22166 22170 22945 23476 22869 23726 23035 22431 22777 22859 22861 22824 22693 22757 22651 22171 22630 23619 22941 22957 22366 23098 22998 22427 23168 22729 23459 23625 23627 22748 23054 23063 23578 23177 22352 22353 22354 23597 22736 22618 22828 22458 22695 22644 23141 22211 23059 23079 23078 23167 23464 22184 22804 22392 22234 22235 22289 22795 23172 23173 22592 22271 22914

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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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