Recall – Radiation therapy system has potential for incorrect target position

Company: Hitachi America, Ltd., Power Systems Division
Date of Enforcement Report: 7/3/2019
Class II

PRODUCT

PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.

Recall Number: Z-1892-2019

REASON

There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems.

RECALLING FIRM/MANUFACTURER

Hitachi America, Ltd., Power Systems Division on 7/3/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3

DISTRIBUTION

US Nationwide and International

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.