Philips North America, LLC recalls Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator: 866417 Inte…

Recall date

April 29, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1772-2019

FDA classification

Class III

Brand / firm

Philips North America, LLC

Sold / distributed

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 G…

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.