FDA Device recall Z-1771-2019
Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Informa…
- FDA Device
- Class III
- terminated
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class III recall of Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Informa… by Philips North America, citing 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 Cen….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1771-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-04-29 |
| Published | 2019-06-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
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
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
Identifiers
| code_info | 866389 Patient Information Center iX B.01 (or later) 866390 Patient Information Center iX B.01 upgrade (or later) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1771-2019%22
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