Z-1397-2018 Class II Terminated
FDA device recall Z-1397-2018 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
MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 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: 3383 5474 3296 3591 3618 3103 3986 3629 3136 70-4323 5092 3639 3274 2855 3644 4018 70-4347 3939
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1397-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026