Mitsubishi VERO MHI-TM2000 Linear Accelerator Recall for Gantry Angle Error
Mitsubishi Heavy Industries is recalling VERO MHI-TM2000 Linear Accelerators because the operator console may set an incorrect gantry angle for the first beam of an IMRT treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a defect could lead to an erroneous radiation treatment, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Mitsubishi Heavy Industries, Ltd. is recalling the VERO MHI-TM2000 Linear Accelerator System. The recall involves 25 units worldwide, including 4 units in the United States. The affected units are distributed nationwide, including in New York, Texas, Florida, and Ohio. The specific units affected are identified by software versions 3.5.8, 3.5.2, and lower, and serial numbers 201902, 203901, 203919, and 203924.
The recall is due to a potential software defect where the Operator Console could set an incorrect Gantry angle for the first beam of an Intensity-Modulated Radiation Therapy (IMRT) treatment under certain specific conditions. If the Gantry angle is incorrectly set and the error is not detected, an erroneous treatment would be administered to the patient.
Healthcare facilities using these devices should contact Mitsubishi Heavy Industries, Ltd. for further instructions on how to address the issue. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- 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.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Software version 3.5.8
- 3.5.2 and lower
- Serial Numbers: 201902
- 203901
- 203919
- 203924
Distribution
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