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Recall Observatory FDA recall evidence

Device product

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

Z-1289-2022

May 03, 2022

Class II

Product summary

Firm
Canon Medical System, USA, INC.
Event
Event 90246
Status
Ongoing
Classification
Class II
Quantity
6 systems
Official record key
device-enforcement:Z-1289-2022

Official wording

Reason: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.