MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
FDA device recall Z-1574-2015 · posted 2015-05-01 · Terminated
Recall details
- Recalling firm
- MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
- Reason for recall
- 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.
- Action taken
- MITSUBISHI HEAVY INDUSTRIES, LTD. has issued a Safety Alert for the MHI-TM2000 Linear Accelerator System dated April 10, 2015, due to a software issue. Customers were advised not to deliver therapeutic X-ray if popup warning message show is displayed during treatment. Instructions were provided if therapeutic radiation is delivered during popup warning. Customers with questions should contact the Customer Service Representative by calling 1-800-597-5911, Monday through Friday or email: us.support@brainlab.com. **CAPA** Correction software for this issue has a tentative availability date of June 2015. Estimated software update completion date would be end of October 2015.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 11 units total
- Distribution
- Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.
- Date initiated
- 2015-04-17
- Date posted
- 2015-05-01
- Date terminated
- 2017-04-11
- Location
- HIROSHIMA, 4-CHOME KAN-ON-SHIN-MACHI, Japan
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS (K122450) | Mitsubishi Heavy Industries, Ltd. | 2012-10-03 |
| MHI-TM2000 LINEAR ACCELERATOR SYSTEM (K072047) | Mitsubishi Heavy Industries, Ltd. | 2007-08-29 |