CanadaAlphenix INFX-8000C and INFX-8000V main units with serial numbers PFD2492006; QWB2472001; QWB2512002; QWB2567001; QEA2512001; QUB2482003; QUB2492004; QUB2472002; QUB2557003; QUB2512005; Q1B2472001; PUB2227001; PVD2292001; P5D2492002; QDB2547002 are affected. An internal error can occur if F-STORE or image acquisition is performed while the CAAS clinical analysis function is in use; the manufacturer says this is a software problem and the error will not occur if F-STORE or image acquisition are performed after terminating CAAS clinical analysis. Contact the manufacturer for additional information.
What's being recalled
Companies: Canon Medical Systems Corporation, 1385, Shimoishigami, Otawara-Shi, Tochigi-Ken, Japan, 324-8550.
How to identify it
Affected products: Alphenix INFX-8000c-Main Unit; Lot or serial number: S/N: PFD2492006; Model or catalogue number: INFX-8000C/PF
Affected products: Alphenix INFX-8000c-Main Unit; Lot or serial number: S/N: QWB2472001; Model or catalogue number: INFX-8000C/QW
Affected products: Alphenix INFX-8000c-Main Unit; Lot or serial number: S/N: QWB2512002; Model or catalogue number: INFX-8000C/QW
Affected products: Alphenix INFX-8000c-Main Unit; Lot or serial number: S/N: QWB2567001; Model or catalogue number: INFX-8000C/QW
Affected products: Alphenix INFX-8000c-Main Unit; Lot or serial number: S/N: QEA2512001; Model or catalogue number: INFX-8000C/QE
Affected products: Alphenix INFX-8000c-Main Unit; Lot or serial number: S/N: QUB2482003; Model or catalogue number: INFX-8000C/QU
Affected products: Alphenix INFX-8000c-Main Unit; Lot or serial number: S/N: QUB2492004; Model or catalogue number: INFX-8000C/QU
Affected products: Alphenix INFX-8000c-Main Unit; Lot or serial number: S/N: QUB2472002; Model or catalogue number: INFX-8000C/QU
Affected products: Alphenix INFX-8000c-Main Unit; Lot or serial number: S/N: QUB2557003; Model or catalogue number: INFX-8000C/QU
Affected products: Alphenix INFX-8000c-Main Unit; Lot or serial number: S/N: QUB2512005; Model or catalogue number: INFX-8000C/QU
Affected products: Alphenix INFX-8000v-Main Unit; Lot or serial number: S/N: Q1B2472001; Model or catalogue number: INFX-8000V/Q1
Affected products: Alphenix INFX-8000v-Main Unit; Lot or serial number: S/N: PUB2227001; Model or catalogue number: INFX-8000V/PU
Affected products: Alphenix INFX-8000v-Main Unit; Lot or serial number: S/N: PVD2292001; Model or catalogue number: INFX-8000V/PV
Affected products: Alphenix INFX-8000v-Main Unit; Lot or serial number: S/N: P5D2492002; Model or catalogue number: INFX-8000V/P5
Affected products: Alphenix INFX-8000v-Main Unit; Lot or serial number: S/N: QDB2547002; Model or catalogue number: INFX-8000V/QD
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)