Z-1437-2017 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

Recall Details

Product Type
Devices
Report Date
March 15, 2017
Initiation Date
January 25, 2017
Termination Date
October 6, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
35 systems

Product Description

MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer

Reason for Recall

Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.

Distribution Pattern

Nationwide Distribution

Code Information

Device Model Number 8515520 Serial numbers: 3009 2958 2863 2972 2646 3079 2516 2962 3055 1452 2702 2125 3066 2689 2228 2564 2507 1904 3075 2375 3013 3068 2596 3025 3049 2965 2045 3084 2855 2906 2292 2384 2067 2818 3089