FDA-Device2018-11-07Class II
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)
Hazard
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
Sold states
US nationwide distribution
Affected count
35 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0297-2019More Siemens Medical Solutions USA, Inc recalls
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