Alphenix Systems
Brand(s)
Last updated
Summary
Product
Alphenix Systems
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Alphenix INFX-8000c-Main Unit | S/N: PFD2492006 | INFX-8000C/PF |
| Alphenix INFX-8000c-Main Unit | S/N: QWB2472001 | INFX-8000C/QW |
| Alphenix INFX-8000c-Main Unit | S/N: QWB2512002 | INFX-8000C/QW |
| Alphenix INFX-8000c-Main Unit | S/N: QWB2567001 | INFX-8000C/QW |
| Alphenix INFX-8000c-Main Unit | S/N: QEA2512001 | INFX-8000C/QE |
| Alphenix INFX-8000c-Main Unit | S/N: QUB2482003 | INFX-8000C/QU |
| Alphenix INFX-8000c-Main Unit | S/N: QUB2492004 | INFX-8000C/QU |
| Alphenix INFX-8000c-Main Unit | S/N: QUB2472002 | INFX-8000C/QU |
| Alphenix INFX-8000c-Main Unit | S/N: QUB2557003 | INFX-8000C/QU |
| Alphenix INFX-8000c-Main Unit | S/N: QUB2512005 | INFX-8000C/QU |
| Alphenix INFX-8000v-Main Unit | S/N: Q1B2472001 | INFX-8000V/Q1 |
| Alphenix INFX-8000v-Main Unit | S/N: PUB2227001 | INFX-8000V/PU |
| Alphenix INFX-8000v-Main Unit | S/N: PVD2292001 | INFX-8000V/PV |
| Alphenix INFX-8000v-Main Unit | S/N: P5D2492002 | INFX-8000V/P5 |
| Alphenix INFX-8000v-Main Unit | S/N: QDB2547002 | INFX-8000V/QD |
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Canon Medical Systems Corporation
1385, Shimoishigami, Otawara-Shi, Tochigi-Ken, Japan, 324-8550
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81590
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