Z-1541-2008

IntelliVue Clinical Information Portfolio Critical Care Release D, Version D.00.00 Product Number: 865047...

Name: Z-1541-2008 IntelliVue Clinical Information Portfolio Critical Care Release D, Version D.00.00 Product Number: 865047...
Creator: Philips Medical Systems
Published: 2008-03-04
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-03-04 / Terminated / root cause: software

FDA source

Philips Medical Systems began a recall of IntelliVue Clinical Information Portfolio Critical Care Release D, Version D.00.00 Product Number: 865047. This device is a clinical information system... on 2008-03-04. The reason FDA records is "Medications prescribed for one patient were printed on the record of another patient". 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-1541-2008
Status: Terminated
Initiated: 2008-03-04
Posted: 2008-08-23
Terminated: 2016-08-15
Recalling firm: Philips North America LLC
Product: IntelliVue Clinical Information Portfolio Critical Care Release D, Version D.00.00 Product Number: 865047. This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records and computation of drug dosage.
Product code: DXJ Display, Cathode-Ray Tube, Medical
Reason for recall: Medications prescribed for one patient were printed on the record of another patient.
Root cause tag: software
FDA root cause: Software design
Action: Philips Medical issued letter notification, dated 29 Feb 2008 to customers titled; "Urgent Medical Device Correction Notice". Customers were asked to not solely rely on the Worklist to remind them when to administer orders or interventions until the software has been upgraded. Customers should review the reminders and verify orders and interventions on the Medication Administration Record and Administration record. The correction will be in the form of a software upgrade and will be performed remotely by Philips service personnel.
Quantity in commerce: 138 for products
Distribution: Nationwide Canada, Australia, Austria, Belgium, Denmark., France, Finland, Germany, Great Britain, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, and UAE
Product codes and lots: Version D.00.00

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)