Ion Beam Applications S.A.: Medical Device Recall in 2018 - (Recall #: Z-2470-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

Product Classification:

Class II

Date Initiated: June 27, 2018

Date Posted: July 25, 2018

Recall Number: Z-2470-2018

Event ID: 80384

Reason for Recall:

Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mistreatment for the patient.

Status: Terminated

Product Quantity: 14

Code Information:

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 Pattern:

US Nationwide Distribution in the states of FL, VA, PA, OK, NJ, WA, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated