Z-0845-2018 Class II Terminated
FDA device recall Z-0845-2018 was initiated by Toshiba American Medical Systems Inc on December 29, 2017 and is designated Class II. Reason for recall: During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error. The recall status is terminated (terminated November 29, 2023). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- December 29, 2017
- Termination Date
- November 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
INFX-8000H Fluoroscopic X-Ray Systems
Reason for Recall
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
Distribution Pattern
United States
Code Information
Serial Numbers: A5B1672001, AFA1692002