MHI-TM2000 Linear Accelerator System Software Recall for Communication Errors
Mitsubishi Heavy Industries is recalling 11 MHI-TM2000 Linear Accelerator Systems due to a software defect that allows radiation delivery despite communication errors and prevents saving treatment records.
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 involves a medical device where a software error could lead to unintended radiation delivery or loss of critical treatment records, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Mitsubishi Heavy Industries, Ltd. is recalling 11 units of the MHI-TM2000 Linear Accelerator System, specifically those running Software Version 3.5.0 and 3.5.1. The affected units are distributed worldwide, including in the United States (Florida, New York, Ohio, and Texas) and internationally in Belgium, Italy, Korea, France, and Germany.
The recall is due to a software defect where the operator console allows users to deliver therapeutic radiation to patients even when a specific communication error relevant to imaging conditions has occurred. Additionally, the treatment record, which documents the delivered radiation, cannot be saved when this error occurs.
Healthcare facilities using these systems should contact the manufacturer to arrange for the necessary software updates or repairs. Patients who received treatment on these systems during the affected period should consult their healthcare providers regarding the integrity of their treatment records.
The recalled product
- Product
- MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
- Affected units
- 11
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 (10)
- Serial Numbers: 201902
- 201903
- 202903
- 202905
- 203901
- 203902
- 203903
- 203905
- 203906
- 203919 & 203924
Distribution
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