Philips IntelliVue Monitors Recalled for NBP Measurement Stoppage
Philips is recalling IntelliVue monitors with specific software revisions because the automatic blood pressure measurement series stops in time-synchronized mode.
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: The recall is classified as FDA Class II. The hazard involves the cessation of automatic blood pressure measurements, which is a significant functional failure in a medical monitoring device, but the source does not report specific injuries or hospitalizations, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems, Inc. is recalling 7,587 units of IntelliVue Monitors (models MP5, MP5SC, MP5T, and upgrades) equipped with software revisions J.21.03 or J.21.19. The recall is due to a software defect where the non-invasive blood pressure (NBP) automatic measurement series stops when the monitors are operating in time-synchronized automatic or sequence mode.
These monitors are intended for monitoring and recording physiological parameters for adults, pediatrics, and neonates. The affected units were distributed worldwide, including in the United States and numerous international markets such as Australia, China, Germany, and the United Kingdom.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms f
- Manufacturer
- Philips Medical Systems, Inc.
- Category
- Medical Device — Patient Monitor
- Affected units
- 7,587
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 (2)
- software revisions J.21.03
- J.21.19
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Philips Medical Systems, Inc. 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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