Z-1771-2019Class III

Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal...

Name: Z-1771-2019 Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal...
Creator: Philips North America, LLC
Published: 2019-04-29
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-04-29 / Terminated / root cause: software

FDA source

Philips North America, LLC began a recall of 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... on 2019-04-29. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1771-2019
Classification: Class III
Status: Terminated
Initiated: 2019-04-29
Posted: 2019-06-12
Terminated: 2024-11-22
Recalling firm: Philips North America LLC
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
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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
Root cause tag: software
FDA root cause: 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
Product codes and lots: 866389 Patient Information Center iX B.01 (or later) 866390 Patient Information Center iX B.01 upgrade (or later)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1771-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1771-2019	Class III	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-12
Z-1772-2019	Class III	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-12

Product code MHX

K153702Class IIM3290B Philips IntelliVue Information Center iXPhilips Medical Systems / cleared 2016-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)