Recall Z-0300-2019— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0300-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-06

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-08-06, terminated 2020-04-10. It names one FDA 510(k) clearance: K133259. 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.. Reason: 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-08-06
Terminated: 2020-04-10
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K133259 — YSIO MAXSiemens Medical Solutions USA, Inc.·cleared 2014-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.