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No image published for this recall

Alphenix systems

Official notice

10 Feb 2026

Last checked

10 Feb 2026

Medium riskHealth Canada

An official Health Canada notice concerns Alphenix systems. 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. Published 2026-02-10.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81590

Official notice

2026-02-10

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

S/N: PFD2492006, S/N: QWB2472001, S/N: QWB2512002, S/N: QWB2567001, S/N: QEA2512001, S/N: QUB2482003, S/N: QUB2492004, S/N: QUB2472002, S/N: QUB2557003, S/N: QUB2512005, S/N: Q1B2472001, S/N: PUB2227001, S/N: PVD2292001, S/N: P5D2492002, S/N: QDB2547002

Skus

INFX-8000C/PF, INFX-8000C/QW, INFX-8000C/QE, INFX-8000C/QU, INFX-8000V/Q1, INFX-8000V/PU, INFX-8000V/PV, INFX-8000V/P5, INFX-8000V/QD

Other

RA RA-81590

Model Numbers

INFX-8000C/PF, INFX-8000C/QW, INFX-8000C/QE, INFX-8000C/QU, INFX-8000V/Q1, INFX-8000V/PU, INFX-8000V/PV, INFX-8000V/P5, INFX-8000V/QD

Recall Numbers

81590

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Affected products

Product 1

Lot or serial number - S/N: PFD2492006, Model or catalogue number - INFX-8000C/PF

Product 2

Lot or serial number - S/N: QWB2472001, Model or catalogue number - INFX-8000C/QW

Product 3

Lot or serial number - S/N: QWB2512002, Model or catalogue number - INFX-8000C/QW

Product 4

Lot or serial number - S/N: QWB2567001, Model or catalogue number - INFX-8000C/QW

Product 5

Lot or serial number - S/N: QEA2512001, Model or catalogue number - INFX-8000C/QE

Product 6

Lot or serial number - S/N: QUB2482003, Model or catalogue number - INFX-8000C/QU

Product 7

Lot or serial number - S/N: QUB2492004, Model or catalogue number - INFX-8000C/QU

Product 8

Lot or serial number - S/N: QUB2472002, Model or catalogue number - INFX-8000C/QU

Product 9

Lot or serial number - S/N: QUB2557003, Model or catalogue number - INFX-8000C/QU

Product 10

Lot or serial number - S/N: QUB2512005, Model or catalogue number - INFX-8000C/QU

Product 11

Lot or serial number - S/N: Q1B2472001, Model or catalogue number - INFX-8000V/Q1

Product 12

Lot or serial number - S/N: PUB2227001, Model or catalogue number - INFX-8000V/PU

Product 13

Lot or serial number - S/N: PVD2292001, Model or catalogue number - INFX-8000V/PV

Product 14

Lot or serial number - S/N: P5D2492002, Model or catalogue number - INFX-8000V/P5

Product 15

Lot or serial number - S/N: QDB2547002, Model or catalogue number - INFX-8000V/QD

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Canon.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

81590

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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