CLASS II Device recall · Reported 18 May 2022 · FDA Enforcement Report

Philips Hemodynamic Application recalled by Philips North America

Philips North America is recalling Philips Hemodynamic Application, distributed in Florida, Idaho, New Jersey, Oklahoma, South Carolina, Texas. The recall was initiated on 22 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 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

Quantity recalled77

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1041-2022
FDA event ID: 89878
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Terminated
Recall initiated: 22 Feb 2022
FDA classified: 6 May 2022
Reported: 18 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Medical Software

Timeline

22 Feb 2022	Recall initiated by company
6 May 2022	Classified by FDA	+73 days
18 May 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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.

Where it was distributed

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.

Florida Idaho New Jersey Oklahoma South Carolina Texas

Questions about this recall

Is Philips Hemodynamic Application recalled?

Yes. Philips North America recalled Philips Hemodynamic Application on 22 Feb 2022. The recall is Class II and its status is Terminated. Recall number Z-1041-2022.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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