Hitachi Scenaria Whole-body X-ray CT System recall
Hitachi Scenaria Whole-body X-ray CT System
Why was Hitachi Scenaria Whole-body X-ray CT System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Scenaria units S5002-S5014, S5017-S5044
- Product
- Hitachi Scenaria Whole-body X-ray CT System
- Recalling firm
- Hitachi Medical Systems America Inc
- Quantity
- 39
- Distribution
- 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.
- Recall date
- November 13, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)