Ion Beam Applications S.A.: Medical Device Recall in 2017 - (Recall #: Z-2592-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Proteus 235

Product Classification:

Class II

Date Initiated: February 9, 2017

Date Posted: June 28, 2017

Recall Number: Z-2592-2017

Event ID: 77175

Reason for Recall:

It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers.

Status: Terminated

Product Quantity: 18 systems ( 10 in the US)

Code Information:

Serial Numbers: PAT.000,PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.111, PAT.112, PAT.113, PAT.114, SAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126

Distribution Pattern:

Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated