Kashiwa, N/A, Japan
Hitachi Ltd., Medical System Operations Group recalls
1 recall recorded since 2018, most recently on 8 December 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 8 December 2017
- Terminated
- 11 April 2019
- 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.
- Distribution
- US Distribution in the state of NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1585-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.