Hitachi Scenaria CT System Recalled for Potential Cable Detachment
Hitachi Medical Systems America Inc is recalling 39 Scenaria Whole-body X-ray CT Systems because cables to the controller unit may not be affixed properly, creating a risk of detachment during scanning.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Hitachi Medical Systems America Inc is recalling 39 units of the Hitachi Scenaria Whole-body X-ray CT System. The recall was initiated because there is a possibility that the cables to the controller unit may not be affixed properly. This defect creates the potential for a cable to detach during scanning and eject from the system.
The affected 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 also distributed to the foreign countries of Brazil and Mexico. The specific units involved are Scenaria units S5002-S5014 and S5017-S5044.
This recall is classified as Class II by the FDA. The source text does not report any specific injuries or illnesses associated with this defect. Users of these devices should contact the recalling firm for instructions on how to resolve the issue.
The recalled product
- Product
- Hitachi Scenaria Whole-body X-ray CT System
- Manufacturer
- Hitachi Medical Systems America Inc
- Hazard
- Affected units
- 39
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Scenaria units S5002-S5014
- S5017-S5044
Distribution
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