Home / Recalls / Philips North America, LLC / Z-1772-2019

Z-1772-2019 Class III Terminated

Recalled by Philips North America, LLC — Andover, MA

FDA device recall Z-1772-2019 was initiated by Philips North America, LLC on April 29, 2019 and is designated Class III. 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 d… The recall status is terminated (terminated November 22, 2024). Affected quantity: 180 units.

Recall Details

Product Type: Devices
Report Date: June 19, 2019
Initiation Date: April 29, 2019
Termination Date: November 22, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 180 units

Product Description

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 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

Distribution Pattern

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 Guadeloupe Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kenya Korea Rep Lao Latvia Lebanon Lithuania Luxembourg Macedonia Malaysia Maldives Martinique Mauritius Mayotte Mexico Mongolia Morocco Myanmar Namibia Nepal Netherlands New Caledonia New Zealand Norway Oman Pakistan Palestine Panama Peru Philippines Poland Portugal Puerto Rico Qatar R¿union Romania Russia Russian Fed. Saudi Arabia Serbia Singapore Slovenia South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand Turkey United Kingdom Uruguay Utd Arab Emir Utd.Arab.Emir. Uzbekistan Viet Nam Vietnam White Russia

Code Information

866417 IntelliBridge System C.01 (or later) 866418 IntelliBridge System C.01 upgrade (or later

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