Recall Z-1041-2022— Philips North America Llc

Name: FDA recall Z-1041-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-22

Class II · Terminated

Class II FDA medical device recall by Philips North America Llc, initiated 2022-02-22, terminated 2024-11-06. It names one FDA 510(k) clearance: K181311. 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.. Reason: 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..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Terminated
Initiated: 2022-02-22
Terminated: 2024-11-06
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K181311 — Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V.·cleared 2018-09-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.