Alphenix 4D CT system may stop operating due to system error
The Alphenix 4D CT system may fail to operate due to a system error that activates an interlock restriction. Six affected systems were distributed to hospitals in five U.S. states.
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: This is a Class II recall with no reported injuries or hospitalizations. The hazard is functional failure of diagnostic medical equipment that could impact patient care, but no actual harm has been reported. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Canon Medical System, USA, INC. is recalling Alphenix 4D CT systems with CAS-930A C-arm support (Models INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW). Six systems are included in this recall.
The CT system may experience operational restrictions due to a system error that activates an interlock. When an operator attempts to cancel the associated error message, the CT system may stop operating properly, preventing normal diagnostic imaging.
The affected systems were distributed to facilities in California, Colorado, Florida, New York, and Wyoming.
Facility operators should contact Canon Medical System, USA, INC. for corrective action and further guidance regarding affected equipment.
The recalled product
- Product
- System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
- Manufacturer
- Canon Medical System, USA, INC.
- Hazard
- system-malfunction
- operational-failure
Distribution
Distributed in 5 states:
- CA
- CO
- FL
- NY
- WY
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