VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
This recall has been terminated (originally issued September 16, 2014).
- Recall Initiated
- July 5, 2014
- Posted
- September 16, 2014
- Terminated
- April 1, 2015
- Recall Number
- Z-2653-2014
- Quantity
- 3 units in use in the US
- Official Source
- View on FDA website ↗
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
Distribution
Distributed in the states of NY, FL, and TX.
Lot / Code Info
Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919
Root Cause
Software design
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.