Philips Hemodynamic Application fails to set neonatal blood pressure mode
The Philips Hemodynamic Application, Model 722463, may not automatically switch to neonatal mode for blood pressure monitoring, potentially applying excessive cuff pressure that could cause bruising, nerve damage, or bone deformity in newborns.
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: No illnesses or injuries have been reported. However, this is a risk-of-harm product where serious injury—nerve damage and bone deformity—could occur in a vulnerable population (neonates). Per the rubric, such cases with theoretical but serious potential harm score at most 3.
Plain-English summary
Philips is recalling the Hemodynamic Application, Model 722463, Software Versions R1.2.2 and R1.2.3, used for hemodynamic data visualization and analysis in Philips Interventional Hemodynamic Systems. A total of 77 units have been distributed.
The application has a configuration issue affecting neonatal patients. When a neonatal patient is admitted, the Non-Invasive Blood Pressure (NIBP) mode does not automatically switch to neonatal mode. Without the neonatal setting, the cuff applies inflation pressure higher than 150 mmHg and deflation pressure higher than 5 mmHg.
These excessive cuff pressures could cause bruising, nerve damage, or bone deformity in neonates. The affected devices were distributed to six U.S. states: Florida, Idaho, New Jersey, Oklahoma, South Carolina, and Texas, and to ten countries: France, Germany, India, Mexico, Netherlands, New Zealand, Norway, Poland, South Africa, and Switzerland.
The recalled product
- Product
- Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic System.
- Manufacturer
- Philips North America Llc
- Affected units
- 77
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: B-00884838084544
Distribution
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