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U.S. Department of Health and Human Services

Class 2 Device Recall IntelliVue

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  Class 2 Device Recall IntelliVue see related information
Date Initiated by Firm May 05, 2009
Date Posted July 07, 2009
Recall Status1 Terminated 3 on February 06, 2017
Recall Number Z-1654-2009
Recall Event ID 51979
510(K)Number K992636  
Product Classification patient data collection, storage, and management system - Product Code DXJ
Product Philips IntelliVue Clinical Information Portfolio
Software Version D.0, for patient data collection, storage, and management.
Code Information Serial Numbers: US73900100 US73900101 US73900102 US73900103 US73900104 US73900105 US73900106 US73900107 US73900108 US73900109 US73900110 US73900111 US73900112 US73900113 US73900114 US73900115 US73900116 US73900117 US73900118 US73900119 US73900120 US73900121 US73900122 US73900123 US73900124 US73900125 US73900126 US73900127 US73900128 US73900129 US73900130 US73900131 US73900132 US73900133 US73900134 US73900135 US73900136 US73900137 US73900138 US73900140  US73900141 US73900142 US73900143 US73900144 US73900145 US73900146 US73900147 US73900148 US73900149 US73900150 US73900151 US73900153 US73900154 US73900155 US73900156 US73900157 US73900158 US73900159 US73900160 US73900161 US73900162 US73900163 US73900164 US73900165 US73900166 US73900167 US73900168 US73900169 US73900170 US73900171 US73900172 US73900173 US73900174 US73900175 US73900176 US73900177 US73900178 US73900179 US73900180 US73900181 US73900182 US73900183 US73900184 US73900185 US73900186 US73900187 US73900188 US73900189 US73900190 US73900191 US73900192 US73900193 US73900194 US73900195 US73900197 US73900198 US73900199 US73900200 US73900201 US73900202, and  US73900203.   
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Beth Brouillette
978-659-4884
Manufacturer Reason
for Recall		 Error in therapy scheduling: If scheduled orders are documented and edited prior to the orders' original schedule time, ICIP can create a second instance of the same order marked as pending. A second instance of an order may result in a patient receiving duplicate therapy or patients may not receive their scheduled therapies.
FDA Determined
Cause 2		 Software design
Action Philips notified customers by Urgent Medical Device Correction Notification letter on May 6, 2009. The Customer notifications in the United States will be delivered via UPS. Customer notifications outside the US will be managed by Philips representatives in each affected geography. Customers will be 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 corrections. The corrections will be in the form of software upgrades and will be performed by Philips service personnel. On May 27, 2009, Philips issued the second Urgent Medical Device Correction notification. While customers await the correction of their devices, customers are given the following instructions: Clinicians should not rely solely on the worklist within lCIP to determine actionable orders for the patient until their software is upgraded. Clinical users should always use the medication administration record (MAR) and the administration record in determining the care their patients receive in addition to the critical care worklist.
Quantity in Commerce 105 units
Distribution Worldwide distribution, including USA, Australia, Belgium, China, Denmark, France, Germany, Ireland, Italy, Kenya, Malaysia, Netherlands, Singapore, Spain, Switzerland, Taiwan, UAE, and UK.
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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