Public recall detail

Alphenix Systems

2026-02-10

medium
Radiology Performance
Quick summary

Quick summary: Alphenix Systems. Reason: Performance. Category: Radiology. Date: 2026-02-10.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Alphenix Systems. Reason: Performance. Category: Radiology. Date: 2026-02-10.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandCanon Medical Systems Corporation
ProductAlphenix Systems
IssueMedical devices - Performance
Recall classType II
IdentificationRA-81590

Affected products

ProductAlphenix INFX-8000c-Main Unit
LotS/N: PFD2492006
ModelINFX-8000C/PF
Serial numberS/N: PFD2492006
DescriptionAlphenix INFX-8000c-Main Unit
ProductAlphenix INFX-8000c-Main Unit
LotS/N: QWB2472001
ModelINFX-8000C/QW
Serial numberS/N: QWB2472001
DescriptionAlphenix INFX-8000c-Main Unit
ProductAlphenix INFX-8000c-Main Unit
LotS/N: QWB2512002
ModelINFX-8000C/QW
Serial numberS/N: QWB2512002
DescriptionAlphenix INFX-8000c-Main Unit
ProductAlphenix INFX-8000c-Main Unit
LotS/N: QWB2567001
ModelINFX-8000C/QW
Serial numberS/N: QWB2567001
DescriptionAlphenix INFX-8000c-Main Unit
ProductAlphenix INFX-8000c-Main Unit
LotS/N: QEA2512001
ModelINFX-8000C/QE
Serial numberS/N: QEA2512001
DescriptionAlphenix INFX-8000c-Main Unit
ProductAlphenix INFX-8000c-Main Unit
LotS/N: QUB2482003
ModelINFX-8000C/QU
Serial numberS/N: QUB2482003
DescriptionAlphenix INFX-8000c-Main Unit
ProductAlphenix INFX-8000c-Main Unit
LotS/N: QUB2492004
ModelINFX-8000C/QU
Serial numberS/N: QUB2492004
DescriptionAlphenix INFX-8000c-Main Unit
ProductAlphenix INFX-8000c-Main Unit
LotS/N: QUB2472002
ModelINFX-8000C/QU
Serial numberS/N: QUB2472002
DescriptionAlphenix INFX-8000c-Main Unit
ProductAlphenix INFX-8000c-Main Unit
LotS/N: QUB2557003
ModelINFX-8000C/QU
Serial numberS/N: QUB2557003
DescriptionAlphenix INFX-8000c-Main Unit
ProductAlphenix INFX-8000c-Main Unit
LotS/N: QUB2512005
ModelINFX-8000C/QU
Serial numberS/N: QUB2512005
DescriptionAlphenix INFX-8000c-Main Unit
ProductAlphenix INFX-8000v-Main Unit
LotS/N: Q1B2472001
ModelINFX-8000V/Q1
Serial numberS/N: Q1B2472001
DescriptionAlphenix INFX-8000v-Main Unit
ProductAlphenix INFX-8000v-Main Unit
LotS/N: PUB2227001
ModelINFX-8000V/PU
Serial numberS/N: PUB2227001
DescriptionAlphenix INFX-8000v-Main Unit
ProductAlphenix INFX-8000v-Main Unit
LotS/N: PVD2292001
ModelINFX-8000V/PV
Serial numberS/N: PVD2292001
DescriptionAlphenix INFX-8000v-Main Unit
ProductAlphenix INFX-8000v-Main Unit
LotS/N: P5D2492002
ModelINFX-8000V/P5
Serial numberS/N: P5D2492002
DescriptionAlphenix INFX-8000v-Main Unit
ProductAlphenix INFX-8000v-Main Unit
LotS/N: QDB2547002
ModelINFX-8000V/QD
Serial numberS/N: QDB2547002
DescriptionAlphenix INFX-8000v-Main Unit

Issue

An internal error would occur if F-STORE or image acquisition is performed while CAAS clinical analysis function is used. The manufacturer confirmed that this is caused by a software problem and will not occur if F-STORE or image acquisition are performed after terminating CAAS clinical analysis function.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesCanon Medical Systems Corporation 1385, Shimoishigami, Otawara-Shi, Tochigi-Ken, Japan, 324-8550
Recall date2026-02-02
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81590
Background{}
CompaniesCanon Medical Systems Corporation 1385, Shimoishigami, Otawara-Shi, Tochigi-Ken, Japan, 324-8550
AudiencesHealthcare
Source updated2026-02-10

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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