System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
Check against the official notice below — it lists the full affected range.
Canon Medical System, USA, Inc. is recalling six Alphenix 4D CT systems in combination with CAS-930A C arm Support across five states: California, Colorado, Florida, New York, and Wyoming. The affected systems include model numbers INFX-8000C/BF, INFX-8000C/BH, and INFX-8000C/SW with specific serial numbers listed in the recall notice. The problem involves a system error that may restrict CT operation through an interlock mechanism, potentially causing the CT system to stop operating properly after a user attempts to cancel the error message.
The source document does not specify what remedy is available to consumers or facilities affected by this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.
Reason for recall: CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated. Distribution: U.S.: CA, CO, FL, NY, and WY O.U.S.: None Quantity: 6 systems Lot/code info: UDI-DI Code: 04987670100192 Model Number: INFX-8000C/BF Serial Number/SID: BFA18Y7001 / 30038795 Model Number: INFX-8000C/BH Serial Number / SID: BHB2132002 / 30039730 BHB2132003/ 30039787 BHA1992001 / 30043325 BHC21X2004 / Not Provided Model Number: INFX-8000C/SW Serial Numbers/SID: SWB2162001 / 30052648
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.