Philips IntelliVue Patient Monitor Recall for Outdated Waveform Data
Philips is recalling IntelliVue Patient Monitors because they may display outdated waveform data if powered on continuously for several months, failing to reflect current patient conditions.
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: The recall is classified as FDA Class II. The hazard involves a medical device failing to display current patient data, which poses a risk of harm through misdiagnosis or delayed treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling 50,495 IntelliVue Patient Monitors. The recall is due to a defect where, if the monitors have been powered on continuously for several months, the displayed waveforms may contain outdated data. This failure means the monitors may not accurately reflect the patient's current physiological condition.
The affected monitors are indicated for use by health care professionals to monitor and record physiological parameters for adults, pediatrics, and neonates in a hospital environment. The recall covers units distributed worldwide, including US nationwide distribution. Specific serial numbers for US, VA, and DOD consignees are listed in the recall documentation, while other serial numbers are referenced in a customer list.
Health care facilities should check their inventory against the provided serial number lists. If a monitor is affected, it should be removed from service to prevent reliance on inaccurate patient data. Philips is the recalling firm responsible for this action.
The recalled product
- Product
- IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate…
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Patient Monitor
- Affected units
- 50,495
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)
- Serial Numbers listed for US/VA/DOD Consignees. For OUS serial numbers
Distribution
Distributed nationwide across the United States.
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