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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

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

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.
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