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U.S. Department of Health and Human Services

Class 3 Device Recall Philips Patient Information Center iX

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  Class 3 Device Recall Philips Patient Information Center iX see related information
Date Initiated by Firm April 29, 2019
Create Date June 12, 2019
Recall Status1 Open3, Classified
Recall Number Z-1771-2019
Recall Event ID 82914
510(K)Number K153702  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product 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
Code Information 866389 Patient Information Center iX B.01 (or later) 866390 Patient Information Center iX B.01 upgrade (or later) 
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Philips Customer Services
800-722-9377
Manufacturer 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
FDA Determined
Cause 2		 Software design
Action Philips initiated recall by letter on 4/29/19 identifies the reason for recall, helath risk and to follow the Action to be Taken by Customer/User section of the Customer Information Letter: Users are to be aware that the values in the patients chart or electronic medical record (EMR) may be in error and to confirm infusion pump parameters at the respective pump and only use these values to inform orders or to modify the infusion rate. Philips will provide a software update to customers using the BBraun Space LAN or Arcomed UniqueDoc infusion pumps, at no charge. For further information or support concerning this issue, contact Philips Customer Support at 1-800-722-9377. Complete the attached Reply Card and return to Philips as soon as possible
Quantity in Commerce 12,391
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS
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