Z-1244-2016 Class II Terminated
FDA device recall Z-1244-2016 was initiated by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK on December 15, 2015 and is designated Class II. Reason for recall: Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" under specific conditi… The recall status is terminated (terminated April 20, 2017). Affected quantity: 25 devices (4 domestically in U.S.A. and 21 internationally).
Recall Details
- Product Type
- Devices
- Report Date
- March 30, 2016
- Initiation Date
- December 15, 2015
- Termination Date
- April 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 devices (4 domestically in U.S.A. and 21 internationally)
Product Description
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
Reason for Recall
Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" under specific conditions.
Distribution Pattern
Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea, & Belgium.
Code Information
Serial numbers: 201901, 201902, 201903, 201904, 201905, 202901, 202902, 202903, 202904, 202905, 202906, 203901, 203902, 203903, 203904, 203905, 203906, 203918, 203919, 203921, 203922, 203924, 203925, 203927 and 203929.