Recall MonitorHealth Products
Edan Patient Monitors
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Obstetrics and gynaecology, Health products - Medical devices - Cardiovascular, Health products - Medical devices - Anaesthesiology
Product: Edan Patient Monitors
Issue: Medical devices - Labelling and packaging
What to do: Customers will be notified with instructions on how to respond.
Audience: Healthcare
Recall class: Type II
Products
| Lot or serial number | Affected products | Model or catalogue number |
|---|---|---|
| Contact the manufacturer. | Vital Signs Monitors | M3A |
| Contact the manufacturer. | Central Monitoring System (For Patient Monitors) | MFM-CMS |
| Contact the manufacturer. | Vital Signs Monitor | IM3 |
| Contact the manufacturer. | Patient Monitor | X12 |
| Contact the manufacturer. | F6 Fetal & Maternal Monitor | F6 EXPRESS |
| Contact the manufacturer. | Central Monitoring System | MFM-CNS LITE |
| Contact the manufacturer. | Vital Signs Monitors | M3 |
| Contact the manufacturer. | Patient Monitor | X10 |
| Contact the manufacturer. | F6 Fetal & Maternal Monitor | F6 |
| Contact the manufacturer. | F9 Fetal & Maternal Monitor | F9 EXPRESS |
| Contact the manufacturer. | Patient Monitor | IM80 |
| Contact the manufacturer. | Central Monitoring System | MFM-CNS |
| Contact the manufacturer. | Patient Monitor | IM60 |
| Contact the manufacturer. | Patient Monitor | X8 |
| Contact the manufacturer. | Patient Monitor | IM50 |
| Contact the manufacturer. | Vital Signs Monitor (Non-Continuous) | IM3S |
| Contact the manufacturer. | Vital Signs Monitors | M3B |
| Contact the manufacturer. | F9 Fetal & Maternal Monitor | F9 |
| Contact the manufacturer. | Patient Monitor | IM70 |
Issue
Labeling issue: an inappropriate publicly routable IP address was used as an example in IFU for demonstrating user-configurable IP address settings. Default setting issue: an inappropriate publicly routable IP address was used as the factory default configuration. However, this IP address is not hard-coded and can be modified by users.