FDA recall Z-2592-2017

Product

Proteus 235

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2017-02-09

Report date

2017-06-28

Termination date

2023-07-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Louvain La Neuve, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2592-2017