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U.S. Department of Health and Human Services

Class 2 Device Recall IntelliVue Clinical Information Portfolio (ICIP)

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 Class 2 Device Recall IntelliVue Clinical Information Portfolio (ICIP)see related information
Date Initiated by FirmMarch 04, 2008
Date PostedAugust 23, 2008
Recall Status1 Terminated 3 on August 15, 2016
Recall NumberZ-1541-2008
Recall Event ID 46961
510(K)NumberK992636 
Product Classification Display, Cathode-Ray Tube, Medical - Product Code DXJ
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.
Code Information Version D.00.00 
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 2		Software design
ActionPhilips 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 Commerce138 for products
DistributionNationwide Canada, Australia, Austria, Belgium, Denmark., France, Finland, Germany, Great Britain, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, and UAE
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DXJ
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