Recall Z-0298-2019 ยท IZZ Table, Radiographic, Non-Tilting, Powered
Siemens Medical Solutions USA, Inc
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.
| Date | Aug 6, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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 pote |
| Quantity | 11 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971452 | MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE Siemens Medical Solutions USA, Inc., May 14, 1997 |