🔍 RecallPedia

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 medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors

Class I - Dangerous
🏥 Medical Devices Recalled: April 29, 2019 Philips North America Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    866389 Patient Information Center iX B.01 (or later) 866390 Patient Information Center iX B.01 upgrade (or later)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips North America, LLC
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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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 medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors

Product Codes/Lot Numbers:

866389 Patient Information Center iX B.01 (or later) 866390 Patient Information Center iX B.01 upgrade (or later)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1771-2019

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