Philips Patient Information Center iX configured with a regional… — Class III medical device recall Z-1771-2019
Terminated recall by Philips North America, LLC, reported 2019-06-19, distributed nationwide. Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmi
| Recall number | Z-1771-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2019-04-29 |
| Classified | 2019-06-12 |
| Reported by FDA | 2019-06-19 |
| Terminated | 2024-11-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, AW, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, KR, LB, LK, LT, LU, LV, MA, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, TH, TR, TW, UY, VN, ZA |
| Quantity | 12,391 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1771-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.