Z-1402-2018 Class II Terminated
FDA device recall Z-1402-2018 was initiated by Siemens Medical Solutions USA, Inc on Feb 14, 2018 and is designated Class II. Reason for recall: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table. The recall status is terminated (terminated May 16, 2019). Affected quantity: 18.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 25, 2018
- Initiation Date
- Feb 14, 2018
- Termination Date
- May 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18
Product Description
PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Reason for Recall
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
Distribution Pattern
Worldwide Distribution- US Nationwide in the states: AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY; and PR. International distribution to Nassau.
Code Information
Serial no: 2958 3832 3241 3574 3519 3922 3924 3361 4036 3302 70-4185 3949 3547 3657 3622 3731 3565 5153
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1402-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026