Agency classClass IIOur severity:Severe FDA (Devices)·Z-2470-2018·Announced 2018-07-25

Ion Beam Applications Recalls Proteus 235 Nozzles Due to Crushing Risk

Ion Beam Applications is recalling 14 Proteus 235 nozzles because they may allow gantry rotation or proton irradiation when accessories are not correctly positioned, posing a risk of crushing or mistreatment.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of crushing injury to patients and users, which aligns with the rubric criteria for a Severe (4) rating involving significant injury reports or risks.

Plain-English summary

Ion Beam Applications S.A. is recalling 14 units of the Proteus 235, Universal Nozzle with snout 300x400 and PBS dedicated nozzle with snout XL. These medical devices are designed to produce and deliver proton beams for the treatment of patients with localized tumors and other conditions susceptible to radiation therapy.

The recall was initiated because the devices may allow gantry rotation or proton irradiation even if apertures or accessories are not correctly positioned in the snout 300x400 or snout XL. This malfunction creates a risk of crushing for the patient and/or user, as well as a risk of mistreatment for the patient.

The affected units were distributed nationwide in the states of Florida, Virginia, Pennsylvania, Oklahoma, New Jersey, Washington, and Texas. The specific patient codes associated with the recalled units are PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.113, PAT.114, PAT.115, PAT.116, PAT.120, PAT.126, and PAT.132.

The recalled product

Product: Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS…
Manufacturer: Ion Beam Applications S.A.
Category: Medical Device — Radiation Therapy Equipment
Hazard: crushing
mistreatment
Affected units: 14

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 (14)

PAT.003
PAT.006
PAT.107
PAT.108
PAT.109
PAT.110
PAT.111
PAT.113
PAT.114
PAT.115
PAT.116
PAT.120
PAT.126
and PAT.132.

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Same manufacturer · Ion Beam Applications S.A.

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Same hazard · crushing