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
Reported: September 15, 2021 Initiated: June 14, 2021 #Z-2434-2021
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
Details
- Recalling Firm
- Ion Beam Applications S.A.
- Units Affected
- 27 worldwide, 11 in U.S.
- 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.
- Location
- Louvain-la-neuve, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ion Beam Applications S.A.. Units affected: 27 worldwide, 11 in U.S..
Why was this product recalled? ▼
Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 15, 2021. Severity: Moderate. Recall number: Z-2434-2021.
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