FDA-Device2015-07-29Class II
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical 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.
Hitachi America, Ltd., Power Systems Division
Hazard
At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. The irradiation control system may be potentially affected when rebooting a part of the control system.
Sold states
Distribution in US (Texas) and Japan
Affected count
3
Manufactured in
1840 Old Spanish Trl, N/A, Houston, TX, United States
Products
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1838-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief