Reported Jun 20, 2018 · Terminated

Proteus ONE and Proteus Plus

Ion Beam Applications S.A.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ion Beam Applications S.A. · Chemin du Cyclotron, 3 · Louvain La Neuve, N/A · N/A

Is this the product you have?

  • Proteus ONE and Proteus Plus
Lot codes and dates
  • Code/Serial Numbers
    • PAT.000
    • PAT.003
    • PAT.006
    • PAT.107
    • PAT.108
    • PAT.109
    • PAT.110
    • PAT.111
    • PAT.112
    • PAT.113
    • PAT.114
    • PAT.115
    • SAT.116
    • SAT.117
    • SAT.119
    • SAT.120
    • SAT.122
    • SAT.123
    • SAT.126
    • SBF.101
Amount recalled
N/A

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Why it was recalled

IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 8, 2019 · Data as of Sep 19, 5:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.