FDA recall Z-1585-2018

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 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.

Distribution

US Distribution in the state of NY.

Key facts

Status

Terminated

Initiation date

2017-12-08

Report date

2018-05-09

Termination date

2019-04-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kashiwa, N/A, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1585-2018