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Recall Observatory FDA recall evidence

Device 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.

Z-0298-2019

August 06, 2018

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 80960
Status
Terminated
Classification
Class II
Quantity
11
Official record key
device-enforcement:Z-0298-2019

Official wording

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.

Code information: Serial Numbers 1137 1138 1525 1121 1132 1529 1074 1531 1472 1136 1119

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.