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U.S. Department of Health and Human Services

Class 2 Device Recall Philips IntelliVue Clinical Information Portfolio

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  Class 2 Device Recall Philips IntelliVue Clinical Information Portfolio see related information
Date Initiated by Firm October 19, 2010
Date Posted November 18, 2010
Recall Status1 Terminated 3 on August 01, 2017
Recall Number Z-0414-2011
Recall Event ID 57039
510(K)Number K992636  
Product Classification Display, cathode-ray tube, medical - Product Code DXJ
Product Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System
Software Version D.00 through D.03.
Code Information Philips IntelliVue Clinical Information Portfolio Release D.XX, where XX is 00, 01, 02 or 03.
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall		 Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending interventions not being generated after the first 24 hours.
FDA Determined
Cause 2		 Software design
Action Philips Healthcare issued an Urgent Medical Device Correction letter dated October 15, 2010 to customers. Customers are asked to follow the guidelines in the "Action to be taken by Customer/User" section of the Urgent Medical Device Correction Notice until they receive their software correction. The correction will be in the form of a software upgrade and will be performed by Philips service personnel. Contact Philips Customer Care Center with questions or concerns about this correction at 1-800-722-9377
Quantity in Commerce 200 units
Distribution Worldwide Distribution: USA, including states of CA, DC, FL, IL, IN, KY, MA, MD, ME, NJ, NY, OK, RI, TX, VA, VT, and WV; and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KENYA, LATVIA, MALAYSIA, NETHERLANDS, NORWAY, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, and the UNITED KINGDOM.
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.
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