Philips IntelliVue Patient Monitor Software Missing Critical Entitlements
Philips IntelliVue Patient Monitor models with software L.x and M.x lack critical monitoring capabilities due to a software update. This could result in incorrect or delayed patient 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: This is an FDA Class II recall involving a medical device with missing software capabilities. Although no illnesses or injuries have been reported, the recall addresses a risk-of-harm product with potential for incorrect or delayed patient treatment due to unavailable monitoring functions.
Plain-English summary
Philips IntelliVue Patient Monitors (models MX400, MX450, MX500, and MX550) with software versions L.x or M.x are missing critical software option entitlements. The entitlements for software options MOS, M06, and M20 were removed during a software update intended to make some options standard capabilities. As a result, patient monitors manufactured with or updated to these software versions will not offer the monitoring capabilities provided by these three options.
The recall was triggered by changes made to reflect some options becoming standard capabilities for software version N.x. In this process, the entitlements for MOS, M06, and M20 were inadvertently removed from software versions L.x and M.x. Additionally, monitors with software version K.x may experience this issue, since K.x is out of support but devices are provided with L.x entitlements for the affected options.
The missing software capabilities could result in incorrect or delayed treatment for patients, as these entitlements govern critical monitoring functions that healthcare professionals depend on. Healthcare facilities using affected monitors should contact Philips to determine if their devices are affected and to obtain remediation or replacement software.
The recalled product
- Product
- IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. 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
- treatment-delay-risk
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: 00884838038752
Distribution
Distributed nationwide across the United States.
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