Recall archive / FDA device enforcement
Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization a... — FDA record Z-1041-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 22, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Philips North America Llc
- Quantity
- 77
- Agency-reported status
- Terminated
- Source record identifier
- Z-1041-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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 Switzerland.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 18, 2022
- Recall initiation date
- Feb 22, 2022
- Center classification date
- May 6, 2022
- Termination date
- Nov 6, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.