Ysio — Class II medical device recall Z-0299-2019
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-11-07, distributed in AL, AR, AZ, CA, CO, DC, FL, GA…. In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, whic
| Recall number | Z-0299-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2018-08-06 |
| Classified | 2018-10-30 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2020-04-10 |
| Distributed | 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, WY |
| Quantity | 142 |
| Serial numbers | 22058, 22166, 22170, 22171, 22175, 22176, 22184, 22208, 22211, 22234, 22235, 22247, 22271, 22288, 22289, 22347, 22350, 22352, 22353, 22354, 22366, 22367, 22392, 22427, 22429 and 117 more |
| Model numbers | 10281013, 10281163, 7042018, 7042034 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0299-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.