# FDA recall Z-1771-2019

> **Philips North  America, LLC** · Class III · device recall initiated 2019-04-29.

## 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

## 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

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 

## Key facts

- **Recall number:** Z-1771-2019
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-29
- **Report date:** 2019-06-19
- **Termination date:** 2024-11-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1771-2019

## Citation

> AI Analytics. FDA recall Z-1771-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1771-2019. Source: US FDA. Licensed CC0.

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