Use caution Medical device recall · FDA · Published February 22, 2022

Philips Neonatal Blood Pressure Monitor Software Recalls: Risk of Injury in Newborns

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1041-2022Medical device Philips ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/61093-philips-neonatal-blood-pressure-monitor-software-recalls-risk-of-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/61093-philips-neonatal-blood-pressure-monitor-software-recalls-risk-of-injury · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1041-2022

Cite this page

“Philips Neonatal Blood Pressure Monitor Software Recalls: Risk of Injury in Newborns.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61093-philips-neonatal-blood-pressure-monitor-software-recalls-risk-of-injury. Based on FDA recall #Z-1041-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1041-2022%22&limit=1).

The FDA announced on Feb. 22, 2022, that Philips North America Llc is recalling its Hemodynamic Application, Model Number 722463, due to a hazard involving incorrect blood pressure settings for neonatal patients. The agency classified the recall as Class II.

How to tell if you have it

Brand: Philips
Product: Philips Hemodynamic Application
Model Number: 722463
Software Version Number: R1.2.2 and R1.2.3
UDI: B-00884838084544
System Serial Numbers: 396 411 225 351 51 46 33 189 132 19 51 924 644 645 646 376 384 487 538 886 14 15 643 1194 220 1238 947 949 950 951 89 657 169 168 413 414 624 565 1060 393 512 278 818 362 123 802 395 576 932 291 834 539 605 161 970 686 761 229 230

The hazard

According to the FDA, when a Neonatal patient is admitted, the Non-Invasive Blood Pressure may not be 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, nerve damage or bone deformity for a neonate.

Context

GovInfoNow's records show Philips North America Llc has 129 other recalls on record since 2017-07-12. Other recent recalls include SmartPath to dStream recalls (2026-08-21) and Spectral CT 7500 Scanner recalls (2026-08-18). Similar product recalls in the sector include Medline Neonatal Breathing Circuits risks reported on 2026-07-13 and Hamilton Medical IntelliCuff Recall issues reported on 2026-05-22.

How to tell if you have this one

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.

Brand
Philips
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Look for the software version number on the monitor; affected units have R1.2.2 or R1.2.3.
Set to Neonatal Mode
Ensure the monitor is set to neonatal mode when a newborn patient is admitted to prevent excessive cuff pressure.

Where it went and when

Where it was distributed

Distributed in 6 states, and outside the U.S.

FDA distribution: “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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Idaho, New Jersey, Oklahoma, South Carolina, Texas.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

Feb 22, 2022Firm started the recall
May 6, 2022FDA classified it Class II
May 18, 2022Published in FDA’s Enforcement Report
Nov 6, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61093-philips-neonatal-blood-pressure-monitor-software-recalls-risk-of-injury">Philips Neonatal Blood Pressure Monitor Software Recalls: Risk of Injury in Newborns (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1041-2022 (February 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1041-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.