Agency classClass IIOur severity:High FDA (Devices)·Z-2139-2018·Announced 2018-06-20

Ion Beam Applications Recalls Proteus ONE and Plus Devices

Ion Beam Applications is recalling Proteus ONE and Proteus Plus medical devices because unauthorized modifications or third-party accessories may pose a safety risk.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a potential safety risk from unauthorized modifications or third-party equipment, which fits the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Ion Beam Applications S.A. is initiating a recall of Proteus ONE and Proteus Plus medical devices. The recall is being conducted to notify customers that the use of non-IBA accessories, third-party equipment, or unauthorized modifications to these devices may pose a safety risk.

The affected units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Specific serial numbers associated with this recall include 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, and SBF.101.

Customers should contact Ion Beam Applications S.A. for instructions on how to proceed with the recall and to ensure the safety of their equipment.

The recalled product

Product: Proteus ONE and Proteus Plus
Manufacturer: Ion Beam Applications S.A.
Category: Medical Device — Radiation Therapy
Hazard: safety-risk
unauthorized-modification

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Ion Beam Applications S.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Ion Beam Applications S.A.

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