Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work

Complete recall history across all FDA and CPSC categories — 6 total recalls

Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (6)

FDA medical device enforcement actions by Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work

Date Product Reason Class
Mar 7, 2016 VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Ac... In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gan... Class II
Dec 15, 2015 MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Inte... Due to Operator Console software anomaly, a change in treatment completion st... Class II
Apr 17, 2015 MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) The operator console allows users to deliver therapeutic radiation to patient... Class II
Dec 2, 2014 VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-... Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Po... Class II
Jul 5, 2014 VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medica... Software Anomaly: If a user changes the calendar setting from Workday to Holi... Class II
Jun 21, 2013 MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or e... Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potenti... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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