Philips North America, LLC 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 c Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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