FDA-Device2013-08-14Class II
MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); 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
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Hazard
Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record into wrong location under certain conditions.
Sold states
Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea.
Affected count
14 (2 in US)
Manufactured in
6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU, HIROSHIMA, N/A, Japan
Products
MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1931-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief