Product Safety Recalls

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Canon Medical System, USA, INC. Recall 90246

Description: System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW

Canon Medical System, USA, INC. Recall 90246 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1289-2022
Event ID90246
Event DescriptionSystem: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
Product TypeDevices
DistributionU.S.: CA, CO, FL, NY, and WY O.U.S.: None
Quantity6 systems
Recall ReasonCT 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.
Device Classification20220706
Device Code InfoUDI-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
Center Classification Date20220624
Recall Initiation Date20220503
Recalling FirmCanon Medical System, USA, INC.
Initial Notification Letter
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