Changeflow GovPing Drug Safety IntelliVue MX Patient Monitor System EC10 Recall
Urgent Enforcement Removed Final

IntelliVue MX Patient Monitor System EC10 Recall

Favicon for recalls-rappels.canada.ca Health Canada Recalls & Safety Alerts
Filed January 21st, 2025
Detected March 11th, 2026
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Summary

Health Canada has issued a Type II recall for the Philips IntelliVue MX Patient Monitor System-IntelliBridge Module EC10. The recall is due to a potential safety issue where the system may fail to alarm for 'No Device Data' INOP, affecting patient safety. Healthcare providers are advised to contact the manufacturer for additional information.

What changed

Health Canada has issued a Type II recall for the Philips IntelliVue MX Patient Monitor System-IntelliBridge Module EC10 (Model 865115). The recall is prompted by a potential safety issue where the monitor, when interfaced with a Hamilton ventilator, may fail to provide an alarm for 'No Device Data' INOP. This failure could compromise patient monitoring and timely intervention.

Healthcare providers using this device should be aware of this potential malfunction. While no specific action is mandated beyond contacting the manufacturer for additional information, this recall highlights the critical importance of ensuring all medical device alarms are functioning correctly. Facilities should review their device maintenance and monitoring protocols to mitigate risks associated with potential alarm failures.

What to do next

  1. Review inventory for affected Philips IntelliVue MX Patient Monitor System-IntelliBridge Module EC10 units.
  2. Contact Philips Medizin Systeme Boblingen Gmbh for additional information regarding the recall.
  3. Assess potential impact on patient monitoring protocols and alarm systems.

Source document (simplified)

Health product recall

IntelliVue MX Patient Monitor System-IntelliBridge Module EC10

Brand(s)

Philips Medizin Systeme Boblingen Gmbh

Last updated

2026-03-11

Summary

Product IntelliVue MX Patient Monitor System-IntelliBridge Module EC10 Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.

Audience Healthcare

Affected products

| Affected products | Lot or serial number | Model or catalog number |
| --- | --- | --- |
| IntelliVue MX Patient Monitor System-IntelliBridge Module EC10 | Not applicable. | 865115 |

Issue

Potential safety issue concerning IntelliVue Patient Monitor (host monitor) with IntelliBridge EC10 Module and EC5 ID-Module interfacing with the Hamilton ventilator failing to alarm for "No Device Data" INOP.

Additional information

Details

Original published date:

2025-01-30

Alert / recall type Health product recall Category Health products - Medical devices - Cardiovascular Companies
| Philips Medizin Systeme Boblingen Gmbh |
| Hewlett-Packard Strasse 2, Boblingen, Germany, 71034 |
Published by Health Canada Audience Healthcare Recall class Type II Recall date

2025-01-21

Identification number RA-76881

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Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
Various Canadian Agencies
Filed
January 21st, 2025
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Healthcare providers Manufacturers
Geographic scope
National (Canada)

Taxonomy

Primary area
Medical Devices
Operational domain
Compliance
Topics
Patient Safety Product Recalls

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