Recall Z-1244-2016— MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Class II · Terminated
Class II FDA medical device recall by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, initiated 2015-12-15, terminated 2017-04-20. It names 3 FDA 510(k) clearances: K152867, K122450, K072047. Product: MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.. Reason: 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..
- Recalling firm
- MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-15
- Terminated
- 2017-04-20
- Firm location
- HIROSHIMA, N/A, Japan
510(k) clearances named in this recall
3 on FDA's record- K152867 — MHI-TM2000 Linear Accelerator System, VERO, Imavis
- K122450 — MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS
- K072047 — MHI-TM2000 LINEAR ACCELERATOR SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.