The Recall Desk
SevereFDA (Devices)·Z-1585-2018·Announced 2018-05-09

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Category
Medical Device — Radiation Therapy Equipment
Hazard
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:

Related recalls

Same hazard · software anomaly

See all →