Class 2 Device Recall Philips Hemodynamic Application

• Date Initiated by Firm: February 22, 2022
• Create Date: May 06, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1041-2022
• Recall Event ID: 89878
• 510(K)Number: K181311
• Product Classification: Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
• 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT Medical Device Correction notification letter dated 2/18/22 was sent to customers. Actions that should be taken by the customer/ user in order to prevent risks for patients. Do not use the Non-Invasive Blood Pressure for Neonatal Patients until Philips has installed a new software revision that will solve this problem. Place this Urgent Medical Device Correction letter with the documentation of the Philips Hemodynamic Application until Philips implements the new software revision. Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Urgent Medical Device Correction letter. Actions planned by Philips to correct the problem. To correct this problem, Philips will install a new software revision to update the Hemodynamic Application to revision Rl.3. This new revision will be available as of March 2022. Philips will be contacting customers with an affected Philips Hemodynamic Application to install the new software revision. Please be assured that maintaining a high level of safety and quality is our highest priority. If you need any further information, please contact your local Philips Cardiology representative.
• Quantity in Commerce: 77
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MWI and Original Applicant = Philips Medical Systems Nederlands B.V.