Canon Medical System, USA, INC.: Medical Device Recall in 2022 - (Recall #: Z-1289-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 3, 2022

Date Posted: July 6, 2022

Recall Number: Z-1289-2022

Event ID: 90246

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.

Status: Ongoing

Product Quantity: 6 systems

Code Information:

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

Distribution Pattern:

U.S.: CA, CO, FL, NY, and WY O.U.S.: None

Voluntary or Mandated:

Voluntary: Firm initiated