CanadaAffected products are Philips IntelliVue patient monitors, including MP40 (M8003A), MX400 (866060), MX850 (866470), MP70 (M8007A), MX (MX700), MP60 (M8005A), MP20 (M8001A), MP5 (M8105A), X2 (M3002A), MP90 (M8010A), MP30 (M8002A), MP80 (M8008A), MP50 (M8004A), MP2 (M8102A) and MX550 (866); lot or serial numbers longer than 10 digits — contact the manufacturer for those numbers. They were recalled because an “infinite alarms off” setting can leave alarms switched off without the user’s awareness, and Philips received complaints of monitors not alarming, including reports of delayed treatment and of severe patient harm or death. Contact the manufacturer for additional information.
What's being recalled
Companies: Philips Medizin Systeme Boblingen Gmbh, Hewlett-Packard Strasse 2, Boblingen, Germany, 71034.
How to identify it
Affected products: IntelliVue MP40 Patient Monitor System - Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M8003A
Affected products: IntelliVue MX400 Patient Monitor; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 866060
Affected products: IntelliVue MX850 Patient Monitor; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 866470
Affected products: IntelliVue MP70 Patient Monitor System - Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M8007A
Affected products: IntelliVue MX Patient Monitor System - Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: MX700
Affected products: IntelliVue MP60 Patient Monitor System - Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M8005A
Affected products: IntelliVue MP20 Patient Monitor System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M8001A
Affected products: IntelliVue MP5 Patient Monitor System - Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M8105A
Affected products: IntelliVue X2 Multi-Measurement Module - Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M3002A
Affected products: IntelliVue MP90 Patient Monitor System - Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M8010A
Affected products: IntelliVue MP30 Patient Monitor System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M8002A
Affected products: IntelliVue MP80 Patient Monitor System - Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M8008A
Affected products: IntelliVue MP50 Patient Monitor System - Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M8004A
Affected products: IntelliVue MP2 Patient Monitor - Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M8102A
Affected products: IntelliVue MX550 Patient Monitor; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 866066
Affected products: IntelliVue MX750 Patient Monitor; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 866471
Affected products: IntelliVue MX500 Patient Monitor; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 866064
Affected products: IntelliVue Patient Monitor; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 866062
Affected products: IntelliVue MX Patient Monitor System - Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: MX800
Affected products: IntelliVue MX100 Patient Monitor; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 867033
Affected products: X3 Multi-Measurement Module; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 867030
The hazard
Philips IntelliVue patient monitors provide a feature for pausing all alarms for a configured timeframe or for switching all alarms off for an infinite period until they are switched back on by the user.
The infinite alarms off feature is an important functionality in specific clinical environments such as the operating room, cath lab or during resuscitations to reduce the audible alarms which may present unnecessary distractions during closely monitored procedures or interventions.
Philips has received complaints that the IntelliVue monitors did not alarm. In some cases, these complaints alleged delayed patient treatment due to the monitors not alarming; and, in some cases, there were reports of severe patient harm or death. It was determined that in these instances the alarms had been switched off for an infinite period, and the user may have been unaware that the alarms were off.
What to do
Contact the manufacturer if you require additional information.
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)