FDA Device recall Z-2653-2014

VERO Linear Accelerator System, Model Number MHI-TM2000

• FDA Device
• Class II
• terminated
• Published 2014-09-24

On 2014-09-24 the FDA classified a Class II recall of VERO Linear Accelerator System, Model Number MHI-TM2000 by Mitsubishi Heavy Industries Hiroshima Machinery Work, citing 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 complete….

Read the official FDA Device notice

Product

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

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

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2653-2014%22

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