Skip to content
Recall Observatory FDA recall evidence

Device product

Proteus 235

Z-2592-2017

February 09, 2017

Class II

Product summary

Firm
Ion Beam Applications S.A.
Event
Event 77175
Status
Terminated
Classification
Class II
Quantity
18 systems ( 10 in the US)
Official record key
device-enforcement:Z-2592-2017

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.