Z-1957-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- April 20, 2020
- Termination Date
- May 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Reason for Recall
Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector
Distribution Pattern
US Nationwide distributions.
Code Information
Serial Numbers: 12425, 109, 10063, 12946