PlainRecalls
FDA Devices Moderate Class II Terminated

Proteus 235, Proton Therapy System

Reported: April 26, 2017 Initiated: March 21, 2017 #Z-1830-2017

Product Description

Proteus 235, Proton Therapy System

Reason for Recall

In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.

Details

Units Affected
2 worldwide, 1 in U.S.
Distribution
Distribution in US (to Louisiana), and France.
Location
Louvain La Neuve, N/A

Frequently Asked Questions

What product was recalled?
Proteus 235, Proton Therapy System. Recalled by Ion Beam Applications S.A.. Units affected: 2 worldwide, 1 in U.S..
Why was this product recalled?
In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 26, 2017. Severity: Moderate. Recall number: Z-1830-2017.