Philips IntelliVue Patient Monitors Shipped with Missing Monitoring Capabilities
Philips IntelliVue patient monitors shipped or updated with software that removes monitoring capabilities, potentially delaying or resulting in incorrect treatment.
What this means for you
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: FDA Class II medical device for patient monitoring where critical software capabilities have been removed due to configuration errors. The recall presents a risk of delayed or incorrect treatment, but no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as 3 (High).
Plain-English summary
Philips North America has recalled IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 (model 866066, UDI 00884838038783) that were shipped or upgraded with incorrect software configurations. During a software update process, entitlements for monitoring options MOS, M06, and M20 were inadvertently removed from software versions L.x and M.x. These monitors are designed for healthcare professionals to monitor and record physiological parameters for adults, pediatrics, and neonates.
Monitors manufactured with or updated to software versions L.x or M.x will not offer certain monitoring capabilities as a result of the missing software options. Monitors with software version K.x (which is out of support) may also experience this issue, as they were provided with L.x entitlements that included the affected options. Nine units have been identified in the United States, with distribution nationwide and internationally to Australia, Austria, Bangladesh, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Netherlands, Portugal, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam.
The missing capabilities create a potential for incorrect or delayed treatment because monitors may not display or alarm for certain physiological parameters. Healthcare professionals should verify that their IntelliVue patient monitors are functioning correctly and displaying all expected monitoring options. Healthcare facilities should contact Philips North America or check the FDA recall notice for guidance on remediation.
The recalled product
- Product
- IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Patient Monitor
- Hazard
- software-malfunction
- missing-alarms
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00884838038783
Distribution
Distributed nationwide across the United States.
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