Hitachi MHI-TM2000 Linear Accelerator Recalled for Software Anomaly
Hitachi is recalling one MHI-TM2000 Linear Accelerator System in New York due to a software anomaly that may prevent patient positioning correction, potentially irradiating the wrong body part.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury due to potential mis-irradiation of the patient.
Plain-English summary
Hitachi Ltd., Medical System Operations Group is recalling one MHI-TM2000 Linear Accelerator System. The device is intended for radiation therapy of lesions, tumors, and other conditions. The recall is limited to distribution in the state of New York.
The recall is due to a system controller software anomaly. This issue may prevent the patient positioning deviation correction from being applied. As a result, the wrong part of the patient may be irradiated during treatment.
The affected unit has serial number 203919. Healthcare facilities and patients who have used this specific device should contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
- Manufacturer
- Hitachi Ltd., Medical System Operations Group
- Affected units
- 1
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 Number: 203919
Distribution
Distributed in 1 state:
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