Recall Z-1585-2018— Hitachi Ltd., Medical System Operations Group
Class II · Terminated
Class II FDA medical device recall by Hitachi Ltd., Medical System Operations Group, initiated 2017-12-08, terminated 2019-04-11. It names 3 FDA 510(k) clearances: K152867, K122450, K072047. Product: MHI-TM2000 Linear Accelerator System Product Usage: 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: Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated..
- Recalling firm
- Hitachi Ltd., Medical System Operations Group
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-08
- Terminated
- 2019-04-11
- Firm location
- Kashiwa, 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 Product Usage: 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
Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
Data sourced from openFDA. This site is unofficial and independent of the FDA.