Recall Z-0297-2019 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Integrated (model number 10746667) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Wireless (model numb
| Date | Aug 3, 2018 |
| Status | Terminated |
| Reason | Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, leading 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 | Siemens Healthineers issued Urgent Medical Device Correction notice dated August 3, 2018, informing potentially affected users via Safety Advisory Notice XP029/18/S to advise of the problem, risk to health, action to be taken (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). The service organization will contact to arrange a date to perform this corrective action with Update Instruction XP031/18/S. |
| Quantity | 35 units |
| Distribution | US nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121513 | MULTIX FUSION Siemens Medical Solution, Aug 10, 2012 |