Philips recalls specific software versions for neonatal blood pressure monitors due to risk of injury from incorrect settings in newborns. Affected units may cause bruising or nerve damage if not set to neonatal mode.
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.
Philips is recalling certain software versions for neonatal blood pressure monitors. If not set to neonatal mode, the monitor could apply excessive pressure that risks bruising, nerve damage, or bone deformity in newborns.
The monitor may not automatically switch to neonatal settings when a newborn is admitted. This causes the blood pressure cuff to inflate at pressures higher than 150 mmHg and deflate at pressures higher than 5 mmHg, which can cause bruising, nerve damage, or bone deformity in newborns.
Newborns using Philips Xperflex Cardio FC2010 patient monitors with the recalled software versions are at risk. Healthcare providers and caregivers who use these monitors for neonatal patients should be most concerned.
Check for the model number 722463 and software versions R1.2.2 or R1.2.3 on the Philips Xperflex Cardio FC2010 patient monitor. The recall applies to units sold in the U.S. with the specified software versions.
Look for the software version number on the monitor; affected units have R1.2.2 or R1.2.3.
Ensure the monitor is set to neonatal mode when a newborn patient is admitted to prevent excessive cuff pressure.
The monitor may not automatically switch to neonatal settings when a newborn is admitted, causing the blood pressure cuff to inflate at pressures higher than 150 mmHg and deflate at pressures higher than 5 mmHg, which can cause bruising, nerve damage, or bone deformity.
Check for the model number 722463 and software versions R1.2.2 or R1.2.3 on the Philips Xperflex Cardio FC2010 patient monitor.
No, but you must ensure the monitor is set to neonatal mode when a newborn is admitted to prevent injury.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1041-2022 — Philips Philips Hello, I own a Philips that is covered by recall Z-1041-2022 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
