CanadaEdan Instruments patient monitors, fetal & maternal monitors, vital signs monitors and central monitoring systems are affected — models include F6, F6 EXPRESS, F9, F9 EXPRESS, IM3, IM3S, IM50, IM60, IM70, IM80, X8, X10, X12, M3, M3A, M3B, MFM‑CNS, MFM‑CNS LITE and MFM‑CMS (contact the manufacturer for lot/serial numbers). They were recalled because an inappropriate publicly routable IP address was used as an example in the instructions for use and was also set as the factory default configuration; the address is not hard‑coded and can be modified by users. Customers will be notified with instructions on how to respond.
What's being recalled
Companies: Edan Instruments, Inc., #15 Jinhui Road, Jinsha Community, Shenzhen, Guangdong, China, 518122.
How to identify it
Affected products: F6 Fetal & Maternal Monitor; Lot or serial number: Contact the manufacturer.; Model or catalogue number: F6
Affected products: F6 Fetal & Maternal Monitor; Lot or serial number: Contact the manufacturer.; Model or catalogue number: F6 EXPRESS
Affected products: Vital Signs Monitor (Non-Continuous); Lot or serial number: Contact the manufacturer.; Model or catalogue number: IM3S
Affected products: Patient Monitor; Lot or serial number: Contact the manufacturer.; Model or catalogue number: IM60
Affected products: Patient Monitor; Lot or serial number: Contact the manufacturer.; Model or catalogue number: IM70
Affected products: Patient Monitor; Lot or serial number: Contact the manufacturer.; Model or catalogue number: IM80
Affected products: Patient Monitor; Lot or serial number: Contact the manufacturer.; Model or catalogue number: IM50
Affected products: F9 Fetal & Maternal Monitor; Lot or serial number: Contact the manufacturer.; Model or catalogue number: F9 EXPRESS
Affected products: F9 Fetal & Maternal Monitor; Lot or serial number: Contact the manufacturer.; Model or catalogue number: F9
Affected products: Vital Signs Monitor; Lot or serial number: Contact the manufacturer.; Model or catalogue number: IM3
Affected products: Patient Monitor; Lot or serial number: Contact the manufacturer.; Model or catalogue number: X10
Affected products: Patient Monitor; Lot or serial number: Contact the manufacturer.; Model or catalogue number: X12
Affected products: Patient Monitor; Lot or serial number: Contact the manufacturer.; Model or catalogue number: X8
Affected products: Central Monitoring System; Lot or serial number: Contact the manufacturer.; Model or catalogue number: MFM-CNS
Affected products: Central Monitoring System; Lot or serial number: Contact the manufacturer.; Model or catalogue number: MFM-CNS LITE
Affected products: Vital Signs Monitors; Lot or serial number: Contact the manufacturer.; Model or catalogue number: M3A
Affected products: Vital Signs Monitors; Lot or serial number: Contact the manufacturer.; Model or catalogue number: M3B
Affected products: Vital Signs Monitors; Lot or serial number: Contact the manufacturer.; Model or catalogue number: M3
Affected products: Central Monitoring System (For Patient Monitors); Lot or serial number: Contact the manufacturer.; Model or catalogue number: MFM-CMS
The hazard
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.
What to do
Customers will be notified with instructions on how to respond.
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)