Z-0300-2019Class II

Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems...

Name: Z-0300-2019 Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems...
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-08-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-08-06 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of... on 2018-08-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0300-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-06
Posted: 2018-10-30
Terminated: 2020-04-10
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.
Product code: KPR System, X-Ray, Stationary
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.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Medical Device Correction notification letters dated 8/6/18 were distributed to customers. The letters instruct customers to do the following: To avoid the above mentioned risk until implementation of the corrective action, it is strongly recommended not to perform up/down movements of the lifting column directly above the patient. Instead, the vertical movement should be completed beside the patient and then the system should be moved horizontally to the patient. How will the issue finally be resolved? Siemens Healthineers is preparing a corrective action that will resolve this potential issue. The corrective action will be distributed via an Update Instruction XP025/18/S and is planned to be available in the end of August 2018. How will the corrective action be implemented and how effective is the corrective action? Our service organization will contact you shortly to arrange a date to perform this corrective action with Update Instruction XP025/18/S. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.
Quantity in commerce: 31
Distribution: 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.
Product codes and lots: Serial Numbers 24077 24221 24256 24237 24263 24327 24297 24283 24288 24289 24172 24174 24186 24129 24277 24142 24304 24109 24176 24049 24058 24039 24234 24323 24105 24295 24121 24230 24276 24194 24281

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0300-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0298-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-30
Z-0299-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-30
Z-0300-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-30

Product code KPR

K133259Class IIYsio MaxSiemens Medical Solutions USA, Inc. / cleared 2014-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)