Class 3 Device Recall Philips IntelliBridge System

• Date Initiated by Firm: April 29, 2019
• Create Date: June 12, 2019
• Recall Status: Open, Classified
• Recall Number: Z-1772-2019
• Recall Event ID: 82914
• Product Classification: unknown device name - Product Code N/A
• Product: Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator:; 866417 IntelliBridge System C.01 (or later); 866418 IntelliBridge System C.01 upgrade (or later); ; Product Usage:; The IntelliBridge System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. The system is not intended for monitoring purposes, nor is the system intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to. The IntelliBridge solution is intended for use in professional healthcare facilities by trained healthcare professionals.
• Code Information: 866417 IntelliBridge System C.01 (or later) 866418 IntelliBridge System C.01 upgrade (or later
• Recalling Firm/ Manufacturer: Philips North America, LLC; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: Philips Customer Services; 800-722-9377
• Manufacturer Reason for Recall: Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX using a LAN driver may be recorded in the patients chart or electronic medical record at exactly 100 times the actual bolus rate, infusion rate and total volume values
• FDA Determined Cause: Software design
• Action: Philips initiated recall by letter on 4/29/19 identifies the reason for recall, helath risk and to follow the Action to be Taken by Customer/User section of the Customer Information Letter: Users are to be aware that the values in the patients chart or electronic medical record (EMR) may be in error and to confirm infusion pump parameters at the respective pump and only use these values to inform orders or to modify the infusion rate. Philips will provide a software update to customers using the BBraun Space LAN or Arcomed UniqueDoc infusion pumps, at no charge. For further information or support concerning this issue, contact Philips Customer Support at 1-800-722-9377. Complete the attached Reply Card and return to Philips as soon as possible
• Quantity in Commerce: 180 units
• Distribution: Worldwide Distribution - US Nationwide Foreign: Andorra Aruba Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Costa Rica Croatia Czech Republic Denmark Dominican Rep Egypt Estonia Finland France French Guiana Germany Ghana Greece Guadeloupe Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kenya Korea Rep Lao Latvia Lebanon Lithuania Luxembourg Macedonia Malaysia Maldives Martinique Mauritius Mayotte Mexico Mongolia Morocco Myanmar Namibia Nepal Netherlands New Caledonia New Zealand Norway Oman Pakistan Palestine Panama Peru Philippines Poland Portugal Puerto Rico Qatar R¿union Romania Russia Russian Fed. Saudi Arabia Serbia Singapore Slovenia South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand Turkey United Kingdom Uruguay Utd Arab Emir Utd.Arab.Emir. Uzbekistan Viet Nam Vietnam White Russia

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.