Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported September 15, 2021
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
Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ion Beam Applications S.a. recalled Proteus 235- designed to produce and deliver a proton beam for the treatment of patients … - a moderate-severity action.
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients … was recalled by Ion Beam Applications S.a. in September 15, 2021. Reason: Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information…. Check the official notice for the remedy. Verify recall #Z-2434-2021 with the FDA Devices before acting.
The recall
Ion Beam Applications S.a. issued this moderate-severity FDA Devices recall-Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information….
- Moderate
- severity level
- Class II
- classification
- September 15, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2434-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2434-2021) was formally reported on September 15, 2021, with the manufacturer initiating the action on June 14, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ion Beam Applications S.a. is listed as the recalling firm, operating out of Louvain-la-neuve, N/A. Federal records list the affected scope as 27 worldwide, 11 in U.S..
The documented reason for this recall is: 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 data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
27 worldwide, 11 in U.S.
Related Recalls
6
3 from same agency
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2434-2021 |
| Date reported | September 15, 2021 |
| Date initiated | June 14, 2021 |
| Recalling firm | Ion Beam Applications S.a. |
| Firm location | Louvain-la-neuve, N/A |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2434-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2434-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 15, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.