Recall MonitorHealth Products
Alphenix Systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Alphenix Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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.