Philips IntelliVue Patient Monitors with disabled monitoring software options
Philips IntelliVue Patient Monitors (MX400/450/500/550) with software versions L.x or M.x lack required monitoring capabilities due to removed software entitlements. The missing features could lead to incorrect or delayed patient treatment.
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: FDA Class II recall affecting a high-risk medical device. No illnesses or injuries are reported. The potential for incorrect or delayed treatment due to missing monitoring capabilities qualifies this as a risk-of-harm product where injury has not yet been reported, meeting the High (3) severity criterion.
Plain-English summary
Philips IntelliVue Patient Monitors (models MX400, MX450, MX500, MX550) with software versions L.x or M.x contain a software entitlement error. When software was updated to version N.x, three monitoring options (MOS, M06, M20) became standard capabilities. However, these options were incorrectly removed from the licensing system for versions L.x and M.x. Approximately 49 units were shipped or upgraded with the incorrect configuration. Devices running older K.x software (which is out of support) that were provisioned with L.x entitlements may also experience this issue.
These monitors are intended for use by healthcare professionals to monitor and record multiple physiological parameters in adults, pediatrics, and neonates. The missing monitoring capabilities create a potential for incorrect or delayed treatment because healthcare providers may lack complete patient data needed for proper clinical decision-making.
Affected devices have been distributed nationwide and internationally, including 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. Healthcare facilities currently operating these devices should contact Philips to verify their software version and receive corrected software entitlements. Facilities must ensure all required monitoring capabilities are enabled before continuing clinical use.
The recalled product
- Product
- IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics…
- Manufacturer
- Philips North America Llc
- Affected units
- 49
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: 00884838038769
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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