Philips IntelliVue MX4O Monitor Recall for Alarm Failure
Philips is recalling IntelliVue MX4O Patient Wearable Monitors that may fail to switch to Monitor Mode with audible alarms if the connection to the central system is lost.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a failure to provide audible alarms poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling 2,648 units of the IntelliVue MX4O WLAN Patient Wearable Monitor. The recall involves specific product and exchange part numbers containing Hardware Revision C.01.01 with Software Revisions B.05 or B.06. These devices are indicated for use by health care professionals to monitor physiological parameters of adults and pediatrics in hospital environments and during transport.
The recall is due to a defect where the monitor may not automatically switch to Monitor Mode with audible alarms when its association with the central monitoring system is unsuccessful. The MX4O is designed to connect to the IntelliVue Information Center via a wireless network, which provides the primary patient monitoring and alarming function. The device does not automatically provide local monitoring or alarming when connected to the Information Center.
The affected units were distributed worldwide, including in the United States, Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Italy, Netherlands, Norway, Qatar, Singapore, South Africa, Sweden, Switzerland, and the United Kingdom. Health care professionals should contact Philips for instructions on how to address the issue.
The recalled product
- Product
- Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals…
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 2,648
Distribution
Distributed nationwide across the United States.
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