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Edan patient monitors

Official notice

23 Dec 2025

Last checked

23 Dec 2025

Medium riskHealth Canada

An official Health Canada notice concerns Edan patient monitors. 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. Published 2025-12-23.

What to do now

Customers will be notified with instructions on how to respond.

Recall number

81393

Official notice

2025-12-23

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Skus

F6, F6 EXPRESS, IM3S, IM60, IM70, IM80, IM50, F9 EXPRESS, F9, IM3, X10, X12, X8, MFM-CNS, MFM-CNS LITE, M3A, M3B, M3, MFM-CMS

Other

RA RA-81393

Model Numbers

F6, F6 EXPRESS, IM3S, IM60, IM70, IM80, IM50, F9 EXPRESS, F9, IM3, X10, X12, X8, MFM-CNS, MFM-CNS LITE, M3A, M3B, M3, MFM-CMS

Recall Numbers

81393

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Affected products

Product 1

Affected products - F6 Fetal & Maternal Monitor, Lot or serial number - Contact the manufacturer., Model or catalogue number - F6

Product 2

Affected products - F6 Fetal & Maternal Monitor, Lot or serial number - Contact the manufacturer., Model or catalogue number - F6 EXPRESS

Product 3

Affected products - Vital Signs Monitor (Non-Continuous), Lot or serial number - Contact the manufacturer., Model or catalogue number - IM3S

Product 4

Affected products - Patient Monitor, Lot or serial number - Contact the manufacturer., Model or catalogue number - IM60

Product 5

Affected products - Patient Monitor, Lot or serial number - Contact the manufacturer., Model or catalogue number - IM70

Product 6

Affected products - Patient Monitor, Lot or serial number - Contact the manufacturer., Model or catalogue number - IM80

Product 7

Affected products - Patient Monitor, Lot or serial number - Contact the manufacturer., Model or catalogue number - IM50

Product 8

Affected products - F9 Fetal & Maternal Monitor, Lot or serial number - Contact the manufacturer., Model or catalogue number - F9 EXPRESS

Product 9

Affected products - F9 Fetal & Maternal Monitor, Lot or serial number - Contact the manufacturer., Model or catalogue number - F9

Product 10

Affected products - Vital Signs Monitor, Lot or serial number - Contact the manufacturer., Model or catalogue number - IM3

Product 11

Affected products - Patient Monitor, Lot or serial number - Contact the manufacturer., Model or catalogue number - X10

Product 12

Affected products - Patient Monitor, Lot or serial number - Contact the manufacturer., Model or catalogue number - X12

Product 13

Affected products - Patient Monitor, Lot or serial number - Contact the manufacturer., Model or catalogue number - X8

Product 14

Affected products - Central Monitoring System, Lot or serial number - Contact the manufacturer., Model or catalogue number - MFM-CNS

Product 15

Affected products - Central Monitoring System, Lot or serial number - Contact the manufacturer., Model or catalogue number - MFM-CNS LITE

Product 16

Affected products - Vital Signs Monitors, Lot or serial number - Contact the manufacturer., Model or catalogue number - M3A

Product 17

Affected products - Vital Signs Monitors, Lot or serial number - Contact the manufacturer., Model or catalogue number - M3B

Product 18

Affected products - Vital Signs Monitors, Lot or serial number - Contact the manufacturer., Model or catalogue number - M3

Product 19

Affected products - Central Monitoring System (For Patient Monitors), Lot or serial number - Contact the manufacturer., Model or catalogue number - MFM-CMS

Product 20

Lot or serial number - Contact the manufacturer., Model or catalogue number - F6

Product 21

Lot or serial number - Contact the manufacturer., Model or catalogue number - F6 EXPRESS

Product 22

Lot or serial number - Contact the manufacturer., Model or catalogue number - IM3S

Product 23

Lot or serial number - Contact the manufacturer., Model or catalogue number - IM60

Product 24

Lot or serial number - Contact the manufacturer., Model or catalogue number - IM70

Product 25

Lot or serial number - Contact the manufacturer., Model or catalogue number - IM80

Product 26

Lot or serial number - Contact the manufacturer., Model or catalogue number - IM50

Product 27

Lot or serial number - Contact the manufacturer., Model or catalogue number - F9 EXPRESS

Product 28

Lot or serial number - Contact the manufacturer., Model or catalogue number - F9

Product 29

Lot or serial number - Contact the manufacturer., Model or catalogue number - IM3

Product 30

Lot or serial number - Contact the manufacturer., Model or catalogue number - X10

Product 31

Lot or serial number - Contact the manufacturer., Model or catalogue number - X12

Product 32

Lot or serial number - Contact the manufacturer., Model or catalogue number - X8

Product 33

Lot or serial number - Contact the manufacturer., Model or catalogue number - MFM-CNS

Product 34

Lot or serial number - Contact the manufacturer., Model or catalogue number - MFM-CNS LITE

Product 35

Lot or serial number - Contact the manufacturer., Model or catalogue number - M3A

Product 36

Lot or serial number - Contact the manufacturer., Model or catalogue number - M3B

Product 37

Lot or serial number - Contact the manufacturer., Model or catalogue number - M3

Product 38

Lot or serial number - Contact the manufacturer., Model or catalogue number - MFM-CMS

Risk / 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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Edan Instruments.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

81393

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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