MHI-TM2000 Linear Accelerator Software Recall for Treatment Status Error
Mitsubishi Heavy Industries is recalling MHI-TM2000 Linear Accelerator Systems due to a software anomaly that may incorrectly change a patient's treatment status to 'Untreated'.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a software anomaly affecting documentation status without reporting any patient injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary measures where harm has not been reported.
Plain-English summary
Mitsubishi Heavy Industries, Ltd. is recalling 25 MHI-TM2000 Linear Accelerator Systems (Software Version 3.0.0 and after) due to a software anomaly in the Operator Console. The affected devices are used for radiation therapy of lesions, tumors, and other conditions where radiation therapy is indicated.
The recall is necessary because, under specific conditions, the software may alter the treatment completion status of the last patient of the day from "Completed (or Discontinued)" to "Untreated." This error could lead to incorrect documentation of patient treatment history.
The recall affects 25 devices, with 4 located domestically in the United States and 21 located internationally. In the U.S., the devices were distributed in Florida, New York, Ohio, and Texas. Internationally, they were distributed in France, Germany, Japan, Italy, Korea, and Belgium. Specific serial numbers are listed in the official recall notice. Healthcare providers should contact the manufacturer for further instructions on remediation.
The recalled product
- Product
- MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy 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 (20)
- Serial numbers: 201901
- 201902
- 201903
- 201904
- 201905
- 202901
- 202902
- 202903
- 202904
- 202905
- 202906
- 203901
- 203902
- 203903
- 203904
- 203905
- 203906
- 203918
- 203919
- 203921
Distribution
Related recalls
Same manufacturer · MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
See all →- HighMitsubishi VERO MHI-TM2000 Linear Accelerator Recall for Gantry Angle Error
FDA (Devices) · 2016-04-06
- HighMHI-TM2000 Linear Accelerator System Software Recall for Communication Errors
FDA (Devices) · 2015-05-13
- HighMitsubishi VERO Linear Accelerator Software Recall for Image Display Error
FDA (Devices) · 2014-12-24
- HighMitsubishi Vero Linear Accelerator Software Recall for Treatment Status Errors
FDA (Devices) · 2014-09-24
- HighMitsubishi VERO Linear Accelerator Software Recall for Data Storage Error
FDA (Devices) · 2013-08-14
Same hazard · software anomaly
See all →- HighMiniMed 780G Insulin Pump Software Anomaly Recall
FDA (Devices) · 2026-07-15
- HighPlum Solo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Duo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Duo infusion pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- SevereIvenix pump software may report false battery health and shut down
FDA (Devices) · 2026-06-10