Z-2434-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 15, 2021
- Initiation Date
- June 14, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 worldwide, 11 in U.S.
Product Description
Proteus 235- 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
Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of FL, OK, VA, IL, NJ, TN, WA, LA, TX, MI and the countries of Germany, Italy, Russia, Sweden, India, Japan, France, England, Spain.
Code Information
PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.110 (US), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (EU), SBF.109 (UK), SBF.110 (UK), SBF.113 (US), SBF.115 (UK), SBF.117 (EU).