Z-0271-2020 Class II Terminated
FDA device recall Z-0271-2020 was initiated by Hitachi Medical Systems America Inc on October 16, 2019 and is designated Class II. Reason for recall: There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system. The recall status is terminated (terminated April 30, 2020). Affected quantity: 39.
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2019
- Initiation Date
- October 16, 2019
- Termination Date
- April 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39
Product Description
Hitachi Scenaria Whole-body X-ray CT System
Reason for Recall
There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.
Distribution Pattern
The devices were distributed to the following US states: CA, FL, GA, IA, IN, MD, MT, NC, NY, OH, OK, SD, TN, TX, WY, and PR. The products were distributed to the following foreign countries: Brazil and Mexico.
Code Information
Scenaria units S5002-S5014, S5017-S5044