Recall Z-0298-2019— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0298-2019
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: K971452. Product: AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire 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

K971452 — MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLESiemens Medical Solutions USA, Inc.·cleared 1997-05-14

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

AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire 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.