Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other
Summary
The FDA issued a Class II for Proteus 235- designed to produce and deliver a proton beam for the treatment of by Ion Beam Applications S.A.. Reason: Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause m.
Details
Source
Device Recall
External ID
Z-2434-2021
Action Date
2021-09-15
Status
Ongoing
Category
device
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
Lot/Code Info: 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).
Quantity Affected: 27 worldwide, 11 in U.S.
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-14
Company
Louvain-la-neuve, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ion Beam Applications S.A. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ion Beam Applications S.A.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ion Beam Applications S.A. have FDA actions?
Ion Beam Applications S.A. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2434-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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