Z-1574-2015 Class II Terminated
FDA device recall Z-1574-2015 was initiated by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK on April 17, 2015 and is designated Class II. 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 recall status is terminated (terminated April 11, 2017). Affected quantity: 11 units total.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2015
- Initiation Date
- April 17, 2015
- Termination Date
- April 11, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 units total
Product Description
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
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.
Distribution Pattern
Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.
Code Information
Serial Numbers: 201902, 201903, 202903, 202905, 203901, 203902, 203903, 203905, 203906, 203919 & 203924