FDA-Device2022-05-18Class II
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.
Hazard
When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inflation pressure applied will be higher than 150 mmHg and the deflation pressure will be higher than 5 mmHg. An applied cuff inflation pressure higher than 150mmHg or a deflation pressure higher than 5 could lead to bruising, mmHg nerve damage or bone deformity for a neonate.
Sold states
Devices were distributed to the following US states: FL, ID, NJ, OK, SC and TX. Devices were distributed to the following foreign countries: France, Germany, India, Mexico, Netherlands, New Zealand, Norway, Poland, South Africa, and Switzerland.
Affected count
77
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1041-2022More Philips North America Llc recalls
- FDA-Device2026-07-01Philips Avalon FM20 Fetal Monitor recalled for speaker connector assembly defect
- FDA-Device2026-07-01Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
- FDA-Device2026-07-01Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.
- FDA-Device2026-06-17Philips DigitalDiagnost C90 Flex/Value/Chest/ER recalled for missing seismic stabilization kit
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