MHI-TM2000 Linear Accelerator System recall
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Why was MHI-TM2000 Linear Accelerator System recalled?
The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment record (the delivered radiation record) cannot be saved.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 201902, 201903, 202903, 202905, 203901, 203902, 203903, 203905, 203906, 203919 & 203924
- Product
- MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
- Recalling firm
- MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
- Quantity
- 11 units total
- Distribution
- Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.
- Recall date
- May 13, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)