Philips IntelliVue Patient Monitors lack critical software monitoring options
Philips IntelliVue Patient Monitors (models MX400/450/500/550) with software versions L.x or M.x are missing three monitoring capability options (MOS, M06, M20) due to software changes, creating potential for delayed or incorrect treatment. The recall involves 18 units distributed nationwide and internationally.
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: This is an FDA Class II recall of a medical device with potential for delayed or incorrect patient treatment. No illnesses or injuries have been reported. The hazard is functional and poses risk of patient harm, meeting the rubric criterion for High (3): 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Philips IntelliVue Patient Monitors (models MX400/450/500/550, Model Number 866064) were manufactured or updated with software versions L.x or M.x that have removed software options MOS, M06, and M20. These options previously provided specific monitoring capabilities for patient care.
The software changes were made to reflect certain features becoming standard capabilities. However, in the process, the entitlements for options MOS, M06, and M20 were removed from versions L.x and M.x. Additionally, monitors running the older K.x software version may be affected if they are provided with L.x entitlements, as K.x is no longer supported by the manufacturer.
Without these monitoring options available, clinicians may lack expected monitoring capabilities, creating potential for incorrect or delayed treatment for patients. The affected monitors are in use nationwide and have been distributed to multiple countries including 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.
Healthcare facilities should contact Philips North America LLC immediately if they have affected monitors to determine whether their devices require software updates or other corrective actions.
The recalled product
- Product
- IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. 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
- missing-software-options
- delayed-treatment
- incorrect-treatment
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: 00884838038776
Distribution
Distributed nationwide across the United States.
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