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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 65786
Product Type Devices
Status Ongoing
Recalling Firm MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
City HIROSHIMA
State
Country JP
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-21
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Serial Numbers #s 201902 and 203901 Class II 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. 14 (2 in US) Z-1931-2013
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