Z-0418-2010

IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. Intended for use in...

Name: Z-0418-2010 IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. Intended for use in...
Creator: Philips Healthcare Inc.
Published: 2009-10-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-10-21 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. Intended for use in data collection, storage, and management with... on 2009-10-21. The reason FDA records is "A software defect exists in the ICIP Release 0.02 scheduling function for order management such that if a user edits either the Schedule Time or the Stop Time for an existing order, the corresponding intervention(s) for...". 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-0418-2010
Status: Terminated
Initiated: 2009-10-21
Posted: 2009-11-24
Terminated: 2016-08-22
Recalling firm: Philips North America LLC
Product: IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.
Product code: DXJ Display, Cathode-Ray Tube, Medical
Reason for recall: A software defect exists in the ICIP Release 0.02 scheduling function for order management such that if a user edits either the Schedule Time or the Stop Time for an existing order, the corresponding intervention(s) for the order may not be created.
Root cause tag: software
FDA root cause: Software design
Action: Philips Medical Systems notified accounts by letter on October 21, 2009, of the release ICIP version D.03, which contains a software correction . A Philips representative will schedule the implementation of this upgrade. Please contact the Philips Customer Care Center with questions or concerns about this correction at 1-800-722-9377.
Quantity in commerce: 53 units
Distribution: MD, RI, WV, and TX Australia Belgium Denmark France Italy Malaysia Singapore Spain Switzerland Taiwan United Arab Emirates United Kingdom and Ireland
Product codes and lots: S/W Version D.02

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