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.
Check against the official notice below — it lists the full affected range.
Philips is recalling 77 units of its Hemodynamic Application software (versions R1.2.2 and R1.2.3) used with the Xperflex Cardio FC2010 patient monitor. The software has a problem where neonatal patients admitted to the system may not have their Non-Invasive Blood Pressure automatically set to Neonatal mode. When this occurs, the blood pressure cuff applies excessive pressure—inflation pressure higher than 150 mmHg and deflation pressure higher than 5 mmHg—which can cause bruising, nerve damage, or bone deformity in newborns.
The affected devices were distributed to hospitals and medical facilities in Florida, Idaho, New Jersey, Oklahoma, South Carolina, and Texas in the United States, as well as to facilities in France, Germany, India, Mexico, the Netherlands, New Zealand, Norway, Poland, South Africa, and Switzerland. The recall record does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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. Quantity: 77 Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.