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.
FDA Recall Z-1541-2008 · Posted 2008-08-23
Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeDXJ
Date Initiated2008-03-04
Date Terminated2016-08-15
Product Quantity138 for products
Reason for Recall
Medications prescribed for one patient were printed on the record of another patient.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide Canada, Australia, Austria, Belgium, Denmark., France, Finland, Germany, Great Britain, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, and UAE
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.