Edan Patient Monitors
Brand(s)
Last updated
Summary
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
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| F6 Fetal & Maternal Monitor | Contact the manufacturer. | F6 |
| F6 Fetal & Maternal Monitor | Contact the manufacturer. | F6 EXPRESS |
| Vital Signs Monitor (Non-Continuous) | Contact the manufacturer. | IM3S |
| Patient Monitor | Contact the manufacturer. | IM60 |
| Patient Monitor | Contact the manufacturer. | IM70 |
| Patient Monitor | Contact the manufacturer. | IM80 |
| Patient Monitor | Contact the manufacturer. | IM50 |
| F9 Fetal & Maternal Monitor | Contact the manufacturer. | F9 EXPRESS |
| F9 Fetal & Maternal Monitor | Contact the manufacturer. | F9 |
| Vital Signs Monitor | Contact the manufacturer. | IM3 |
| Patient Monitor | Contact the manufacturer. | X10 |
| Patient Monitor | Contact the manufacturer. | X12 |
| Patient Monitor | Contact the manufacturer. | X8 |
| Central Monitoring System | Contact the manufacturer. | MFM-CNS |
| Central Monitoring System | Contact the manufacturer. | MFM-CNS LITE |
| Vital Signs Monitors | Contact the manufacturer. | M3A |
| Vital Signs Monitors | Contact the manufacturer. | M3B |
| Vital Signs Monitors | Contact the manufacturer. | M3 |
| Central Monitoring System (For Patient Monitors) | Contact the manufacturer. | MFM-CMS |
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Obstetrics and gynaecology
Health products - Medical devices - Cardiovascular
Health products - Medical devices - Anaesthesiology
Companies
Edan Instruments, Inc.
#15 Jinhui Road, Jinsha Community, Shenzhen, Guangdong, China, 518122
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81393
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