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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Multix MT

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 Class 2 Device Recall Siemens Multix MTsee related information
Date Initiated by FirmAugust 06, 2018
Create DateOctober 30, 2018
Recall Status1 Terminated 3 on April 10, 2020
Recall NumberZ-0298-2019
Recall Event ID 80960
510(K)NumberK971452 
Product Classification Table, radiographic, non-tilting, powered - Product Code IZZ
ProductAXIOM 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.
Code Information Serial Numbers 1137 1138 1525 1121 1132 1529 1074 1531 1472 1136 1119 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactAnastasia Sokolova
610-448-6478
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionUrgent 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 Commerce11
DistributionThe 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IZZ
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