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Its4850a intellivue telemetry system-monitor
Official notice
14 Jun 2023
Last checked
14 Jun 2023
An official Health Canada notice concerns Its4850a intellivue telemetry system-monitor. When the MX40 is in standby mode for an extended period without patient surveillance no monitoring or alarming is available because alarms, as designed, cannot be triggered when the MX40 is in standby mode. When users place the MX40 device in standby mode, there are 2 possible outcomes: 1) If a timed duration (i.e., 10 minutes to 4 hours) is used for standby, the MX40 will automatically resume monitoring and end standby mode at the end of the time period; or 2) If infinite duration is used for standby mode, the device will not resume monitoring until standby is manually ended by the user or a "tele battery low" inop condition occurs. While the MX40 device is in standby, physiological monitoring and alarming is stopped. Therefore, there may be a hazardous situation present if a user places an MX40 in standby longer than intended for completion of a patient procedure or test if the device is not taken out of standby. Recall start date: June 2, 2023 Published 2023-06-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73818
Official notice
2023-06-14
The hazard
The hazard
When the MX40 is in standby mode for an extended period without patient surveillance no monitoring or alarming is available because alarms, as designed, cannot be triggered when the MX40 is in standby mode. When users place the MX40 device in standby mode, there are 2 possible outcomes: 1) If a timed duration (i.e., 10 minutes to 4 hours) is used for standby, the MX40 will automatically resume monitoring and end standby mode at the end of the time period; or 2) If infinite duration is used for standby mode, the device will not resume monitoring until standby is manually ended by the user or a "tele battery low" inop condition occurs. While the MX40 device is in standby, physiological monitoring and alarming is stopped. Therefore, there may be a hazardous situation present if a user places an MX40 in standby longer than intended for completion of a patient procedure or test if the device is not taken out of standby. Recall start date: June 2, 2023
How to check if you're affected
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.
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Philips, Its4850a Intellivue Telemetry System-monitor.
Source & status
Source & status
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Tier
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Classification
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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