FDAMarch 7, 2016device
VERO MHI-TM2000 Linear Accelerator System --- 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 recall recorded by the U.S. Food & Drug Administration.
The hazard
In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the first beam of an IMRT treatment if certain specific conditions are met. If Gantry angle for the first beam of IMRT is incorrectly set and if nobody is aware of it, an erroneous treatment would be given to the patient.
What to do
FDA enforcement status: Terminated
Brands named
mitsubishi heavy industries ltd hiroshima machinery workmitsubishimitsubishi heavy
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCRaychy Children's Light Sneakers Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Coin Batteries; Imported by Carina and Rambo2026-06-25
- CPSCVeseacky Pajama Sets Recalled Due to Risk of Serious Injury Death from Burn Hazard; Violate Mandatory Standards for Children's Sleepwear2026-06-18
- CPSCLiKee Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violate Mandatory Standard for Toys; Sold on Amazon by ChilanTech2026-06-11
- CPSCLuminous Fidget Spinner Balls Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys; Sold on Amazon by Anzmtosn2026-05-28
- CPSCJoy Furniture Recalls Talan and Royce Living Room Furniture Sets Due to Risk of Serious Injury from a Fire Hazard2026-05-28
- CPSCResistance Bands Recalled Due to Serious Injury from Impact Hazard; Imported by HomeProGym2026-05-21
- CPSCSuperbobi Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violates Virginia Graeme Baker Pool & Spa Safety Act; Manufactured by Remy&shop2026-05-14
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