Philips Hemodynamic Application — Class II medical device recall Z-1041-2022
Terminated recall by Philips North America Llc, reported 2022-05-18, distributed in FL, ID, NJ, OK, SC, TX. When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philip
| Recall number | Z-1041-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2022-02-22 |
| Classified | 2022-05-06 |
| Reported by FDA | 2022-05-18 |
| Terminated | 2024-11-06 |
| Distributed | FL, ID, NJ, OK, SC, TX |
| Countries outside the US | CH, DE, FR, IN, MX, NL, NO, NZ, PL, ZA |
| Quantity | 77 |
| Serial numbers | 1060, 1194, 123, 1238, 132, 161, 168, 169, 189, 220, 225, 229, 230, 278, 291, 351, 362, 376, 384, 393, 395, 396, 411, 413, 414 and 26 more |
| Model numbers | 722463 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1041-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.