VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Acce

FDA device recall Z-2653-2014 · posted 2014-09-16 · Terminated

Recall details

Recalling firm

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

Reason for recall

Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become Treated (completed) status on the exact day when such change is made, to Untreated status. Furthermore, such treatment would be cloned and mistakenly added to the schedule as Untreated treatment

Action taken

A Preliminary Customer Information Letter (dated 7/4/14) was emailed to customers on 7/05/14 from Mitsubishi's sales and service representative in Germany. The letter informed customers of the potential safety issue associated with the VERO Linear Accelerator and the recommended actions to be taken. A formal URGENT FIELD SAFETY NOTICE Letter (dated 7/15/14) was emailed to customers on 8/07/14 from Mitsubishi's sales and service representative in Germany. The letter instructed customers to ensure that all potential users in the facility are made aware of the safety notification and the recommended actions to be taken.

Root cause

Software design

Status

Terminated

Product code

IYE

Quantity affected

3 units in use in the US

Distribution

Distributed in the states of NY, FL, and TX.

Date initiated

2014-07-05

Date posted

2014-09-16

Date terminated

2015-04-01

Location

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

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