Z-2424-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 18, 2018
- Initiation Date
- May 16, 2018
- Termination Date
- October 16, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Reason for Recall
Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands
Code Information
Serial Numbers: SAT.122 (EU) SAT.132 (EU) SAT.133 (US)