Philips North America, LLC Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medica Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medica
Brand
Philips North America, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
866389 Patient Information Center iX B.01 (or later) 866390 Patient Information Center iX B.01 upgrade (or later)
Philips North America, LLC is recalling Philips Patient Information Center iX configured with a regional setting which uses a comma for a de due to Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface throu. Based on FDA medical device recall database.
Summary derived from FDA notice
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026