Z-0414-2011

Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Version D.00...

Name: Z-0414-2011 Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Version D.00...
Creator: Philips Healthcare Inc.
Published: 2010-10-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-10-19 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Version D.00 through D.03 on 2010-10-19. The reason FDA records is "Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending interventions not being generated after...". 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-0414-2011
Status: Terminated
Initiated: 2010-10-19
Posted: 2010-11-18
Terminated: 2017-08-01
Recalling firm: Philips North America LLC
Product: Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Version D.00 through D.03.
Product code: DXJ Display, Cathode-Ray Tube, Medical
Reason for recall: Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending interventions not being generated after the first 24 hours.
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare issued an Urgent Medical Device Correction letter dated October 15, 2010 to customers. Customers are asked to follow the guidelines in the "Action to be taken by Customer/User" section of the Urgent Medical Device Correction Notice until they receive their software correction. The correction will be in the form of a software upgrade and will be performed by Philips service personnel. Contact Philips Customer Care Center with questions or concerns about this correction at 1-800-722-9377
Quantity in commerce: 200 units
Distribution: Worldwide Distribution: USA, including states of CA, DC, FL, IL, IN, KY, MA, MD, ME, NJ, NY, OK, RI, TX, VA, VT, and WV; and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KENYA, LATVIA, MALAYSIA, NETHERLANDS, NORWAY, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, and the UNITED KINGDOM.
Product codes and lots: Philips IntelliVue Clinical Information Portfolio Release D.XX, where XX is 00, 01, 02 or 03.

Product code DXJ

K992636Class IIHp Carevue 9000 Clinical Information System, Model M2331aHewlett-Packard Co. / cleared 1999-08-31

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)