Recall Z-1772-2019— Philips North America, LLC

Class III FDA medical device recall by Philips North America, LLC, initiated 2019-04-29, terminated 2024-11-22. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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.

Recalling firm

Philips North America, LLC

Classification

Class III

Status

Terminated

Initiated

2019-04-29

Terminated

2024-11-22

Firm location

Andover, MA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.