Class 2 Device Recall IntelliVue Clinical Information Portfolio (ICIP)

• Date Initiated by Firm: March 04, 2008
• Date Posted: August 23, 2008
• Recall Status: Terminated on August 15, 2016
• Recall Number: Z-1540-2008
• Recall Event ID: 46961
• 510(K)Number: K992636
• Product Classification: Display, Cathode-Ray Tube, Medical - Product Code DXJ
• Product: CareVue Chart Release C ,Versions C.00.00 through C.00.06; Product No. 862246. 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.
• Code Information: Softwarre versions: C.00.00 through C.00.06
• Recalling Firm/ Manufacturer: Philips Medical Systems; 3000 Minuteman Road; Andover MA 01810
• For Additional Information Contact: 978-687-1501
• Manufacturer Reason for Recall: Medications prescribed for one patient were printed on the record of another patient.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DXJ and Original Applicant = HEWLETT-PACKARD CO.