FDA recall Z-2424-2018

Product

Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Reason for recall

Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.

Distribution

Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands

Key facts

Status

Terminated

Initiation date

2018-05-16

Report date

2018-07-18

Termination date

2018-10-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Louvain La Neuve, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2424-2018