MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumor

FDA device recall Z-1244-2016 · posted 2016-03-24 · Terminated

Recall details

Recalling firm

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

Reason for recall

Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" under specific conditions.

Action taken

Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" if all the following conditions are met: (1) At least one patient has been treated on the day; (2) A major error occurs when VeroTM/MHI-TM2000 is operated in a mode, other than Clinical Mode, which means Daily Check Mode or Maintenance Mode. (3) The major error is NOT associated with a function that uses therapeutic/ MV radiation parameters, such as an error in Isocenter Check function, etc. Note 1: If the major error is associated with a function that uses therapeutic/MV radiation parameters, the problem that treatment completion status is changed will never occur. The Operator Console changes the treatment completion status in the course of processing the major error. Note 2: Although treatment completion status is changed to "Untreated", its delivered dose result has been correctly saved into R&V System. It has not been lost. Advice on Actions by Customer/Users: 1. Please make sure to perform the operations as described below in case a major error occurred in a mode other than Clinical Mode. (1) Cancel the error. (2) Click [Clinical] button on the left of Operator Console screen. (3) Verify, on R&V System screen, that treatment completion status of the patients who were treated on the day are all correct. The treatment completion status is indicated in different colors as follows depending on the status: Untreated: BLUE, Completed: GRAY, Discontinued: RED. Customers requiring support concerning this issue, please contact the Customer Service Representative: 1-800-597-5911 (Mon - Fri) or via email us.support@brainlab.com. If any other problem is detected, please stop operation and contact the Customer Service representative.

Root cause

Software design

Status

Terminated

Product code

IYE

Quantity affected

25 devices (4 domestically in U.S.A. and 21 internationally)

Distribution

Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea, & Belgium.

Date initiated

2015-12-15

Date posted

2016-03-24

Date terminated

2017-04-20

Location

HIROSHIMA, 4-CHOME KAN-ON-SHIN-MACHI, Japan

Related 510(k) clearances