Philips IntelliVue X3 Patient Monitor Recalled for Blood Pressure Display Errors
Philips is recalling 975 IntelliVue X3 Patient Monitors because they may display incorrect blood pressure values or become inoperable due to touch interface issues.
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 involves a medical device that may provide incorrect clinical data (blood pressure) or become inoperable, posing a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling 975 units of the IntelliVue X3 Patient Monitor (Model 867030). The recall affects devices shipped from June 2017 that were distributed to 48 foreign accounts.
The recall is due to a defect where the monitor's Non-Invasive Blood Pressure (NBP) measurement may intermittently display only mean values instead of diastolic and systolic blood pressure values. This issue is caused by a falsely detected NBP cuff, which leads to incorrect internal NBP settings. Additionally, the monitors may occasionally display a "Check Touch Input" message, rendering the touch interface inoperable.
No specific instructions for consumers are provided in the source text, but the recall is limited to the specific serial numbers listed in the agency's structured data. Healthcare facilities should verify their device serial numbers against the recall list to determine if they are affected.
The recalled product
- Product
- IntelliVue X3 Patient Monitor.
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Patient Monitor
Distribution
Distribution scope not specified by the agency.
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