Philips Patient Information Center iX configured with a regional setting which uses a comma for a...
FDA Device Recall #Z-1771-2019 — Class III — April 29, 2019
Recall Summary
| Recall Number | Z-1771-2019 |
| Classification | Class III — Low risk |
| Date Initiated | April 29, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips North America, LLC |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 12,391 |
Product Description
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
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
Lot / Code Information
866389 Patient Information Center iX B.01 (or later) 866390 Patient Information Center iX B.01 upgrade (or later)
Other Recalls from Philips North America, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0926-2022 | Class II | The IFU for the Autoclavable Temperature Probes... | Feb 7, 2022 |
| Z-1326-2021 | Class II | Philips SureSigns VM4, VM6 and VM8 - Product Us... | Mar 23, 2021 |
| Z-0852-2021 | Class II | Emission Computed Tomography System Image Proce... | Nov 19, 2020 |
| Z-0284-2021 | Class II | Philips Sterilizable Defibrillator Paddles, Swi... | Sep 14, 2020 |
| Z-0285-2021 | Class II | Philips Sterilizable Defibrillator Paddles, Swi... | Sep 14, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.