Z-0938-2018 Class II Terminated
FDA device recall Z-0938-2018 was initiated by Ion Beam Applications S.A. on November 17, 2017 and is designated Class II. Reason for recall: There is a risk of misalignment of the patient when using treatment plans with multiple isocenters. The recall status is terminated (terminated June 14, 2021). Affected quantity: 37.
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)