Z-0938-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- November 17, 2017
- Termination Date
- June 14, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37
Product Description
Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Reason for Recall
There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
Distribution Pattern
Nationally
Code Information
PAT.000 (US), PAT.001 (CN), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.126 (US), SAT.132 (EU), SAT.133 (US), SBF.101 (EU), SBF.105 (US)