medical Class III Updated 2019-06-19

Philips North America, LLC recalls Philips IntelliBridge System configured with a regional sett

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 866417 IntelliBridge System C.01 (or later) 866418 IntelliBridge System C.01 upgrade (or later
View official government recall

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