Mitsubishi VERO Linear Accelerator Software Recall for Image Display Error
Mitsubishi Heavy Industries is recalling four VERO Linear Accelerator systems in the US due to a software anomaly that may display incorrect image angles for patient positioning.
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 is classified as FDA Class II and involves a risk-of-harm product (radiation therapy equipment) where the software error could lead to incorrect patient positioning, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Mitsubishi Heavy Industries, Ltd. is recalling four VERO Linear Accelerator Systems (Model MHI-TM2000) in the United States. The affected units are located in New York, Florida, Texas, and Ohio. The recall involves specific serial numbers: 201902, 203901, 203919, and 203924, and affects software versions 3.1, 3.2, and 3.5.0.
The recall is due to a software anomaly in the Operator Console. The system may incorrectly use image angle information from the first port image for subsequent port image fusions. As a result, the Patient Positioning System (ExacTrac) may display a Digitally Reconstructed Radiograph (DRR) image taken from the wrong angle, rather than the angle intended for the specific port being treated.
Healthcare facilities using these systems should contact Mitsubishi Heavy Industries for instructions on correcting the software issue. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
- Affected units
- 4
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 (4)
- Serial Numbers: 201902
- 203901
- 203919
- and 203924 (US only)
Distribution
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