CLASS II Device recall · Reported 7 Nov 2018 · FDA Enforcement Report

Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model recalled

Siemens Medical Solutions USA is recalling Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model, distributed in 38 states. The recall was initiated on 6 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled142

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0299-2019
FDA event ID: 80960
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 6 Aug 2018
FDA classified: 30 Oct 2018
Reported: 7 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Imaging Equipment

Timeline

6 Aug 2018	Recall initiated by company
30 Oct 2018	Classified by FDA	+85 days
7 Nov 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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.

Where it was distributed

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.

Alabama Arkansas Arizona California Colorado District of Columbia Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Michigan Minnesota Missouri

Questions about this recall

Is Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model recalled?

Yes. Siemens Medical Solutions USA recalled Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model on 6 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-0299-2019.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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