Z-1433-2017 Class II Terminated
FDA device recall Z-1433-2017 was initiated by Siemens Medical Solutions USA, Inc on January 25, 2017 and is designated Class II. 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 … The recall status is terminated (terminated October 6, 2017). Affected quantity: 35 systems.
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 M 6700 (MX) 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 5693908 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