—#167127

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.

FDA product code: IZZ — Table, Radiographic, Non-Tilting, Powered
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K971452
Affected lot / code info: Serial Numbers 1137 1138 1525 1121 1132 1529 1074 1531 1472 1136 1119

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

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.

Timeline

Recall initiated: 2018-08-06
Terminated: 2020-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167127. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.