Mitsubishi Vero Linear Accelerator Software Recall for Treatment Status Errors
Mitsubishi Heavy Industries is recalling three Vero Linear Accelerator systems in the US due to a software defect that may incorrectly mark completed radiation treatments as untreated.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 the hazard involves a risk-of-harm product (radiation therapy equipment) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Mitsubishi Heavy Industries, Ltd. is recalling three units of the Vero Linear Accelerator System, Model Number MHI-TM2000, currently in use in the United States. The affected units are located in New York, Florida, and Texas, and are identified by serial numbers 201902, 203901, and 203919. The recall applies to units running software version 3.0.0 and later.
The recall is due to a software anomaly that affects the treatment scheduling system. If a user changes the calendar setting from Workday to Holiday or vice versa, the system may erroneously change the status of completed treatments to 'Untreated.' Additionally, the system may clone these treatments and mistakenly add them to the schedule as new, untreated sessions. This defect could lead to incorrect tracking of patient treatment history.
The affected devices are intended for radiation therapy of lesions, tumors, and other conditions. Users of these systems should contact Mitsubishi Heavy Industries, Ltd. for further instructions on resolving the software issue.
The recalled product
- Product
- VERO Linear Accelerator System, Model Number MHI-TM2000; 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.
- Affected units
- 3
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 (3)
- Software Version 3.0.0 and after. Serial Numbers 201902
- 203901
- and 203919
Distribution
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