Z-1585-2018 Class II Terminated
FDA device recall Z-1585-2018 was initiated by Hitachi Ltd., Medical System Operations Group on December 8, 2017 and is designated Class II. Reason for recall: Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated. The recall status is terminated (terminated April 11, 2019). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- December 8, 2017
- Termination Date
- April 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
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.
Reason for Recall
Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
Distribution Pattern
US Distribution in the state of NY.
Code Information
Serial Number: 203919