Z-2653-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 24, 2014
- Initiation Date
- July 5, 2014
- Termination Date
- April 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units in use in the US
Product Description
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.
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 Pattern
Distributed in the states of NY, FL, and TX.
Code Information
Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919