Mitsubishi VERO Linear Accelerator Software Recall for Data Storage Error
Mitsubishi Heavy Industries is recalling VERO Linear Accelerator Systems due to a software anomaly that may save treatment records to the wrong location.
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, which falls under the 'High' severity category in the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Mitsubishi Heavy Industries, Ltd. is recalling the MHI-TM2000 Linear Accelerator System, also known as the VERO (TM), for a potential safety issue. The recall affects units with Software Version 3.0.0 revision 13 or earlier. The specific issue is a software anomaly where the system may save treatment delivery records into the wrong location under certain conditions.
The recall covers 14 units worldwide, including 2 units in the United States. Distribution was worldwide, including the US (nationwide, specifically TX and FL) and Belgium, Italy, Japan, and Korea. The affected serial numbers are 201902 and 203901.
This is a Class II recall, meaning there is a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences. The FDA has not reported any illnesses or injuries associated with this specific software anomaly in the provided text.
The recalled product
- Product
- MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and…
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 (1)
- Serial Numbers #s 201902 and 203901
Distribution
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