—#167219

Product

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 number 10893300) with Tube stand 3D V (model number 7042042)

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K121513
Affected lot / code info: Serial Numbers: 40279 10037 1176 40026 1220 40106 40208 40209 40109 40114 40140 40104 40126 40144 10040 10041 40027 40118 40105 40128 40200 40146 10039 40102 40101 40022 40125 40142 40127 40117 40206 1192 1185 40116 40119

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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. Contact service organization for an earlier appointment at 1-800-888-7436. Siemens Healthineers is preparing a corrective action that will resolve this potential issue. The corrective action will be distributed via an Update Instruction XP031/18/S.

Recalling firm

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

Distribution

Distribution pattern: US nationwide distribution

Timeline

Recall initiated: 2018-08-03
Terminated: 2019-11-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167219. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.