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U.S. Department of Health and Human Services

Class 2 Device Recall Philips medical Systems

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  Class 2 Device Recall Philips medical Systems see related information
Date Initiated by Firm October 21, 2009
Date Posted November 24, 2009
Recall Status1 Terminated 3 on August 22, 2016
Recall Number Z-0418-2010
Recall Event ID 53593
510(K)Number K992636  
Product Classification Display, cathode-ray tube, medical - Product Code DXJ
Product IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02.

Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.
Code Information S/W Version D.02
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact SAME
978-687-1501
Manufacturer Reason
for Recall		 A software defect exists in the ICIP Release 0.02 scheduling function for order management such that if a user edits either the Schedule Time or the Stop Time for an existing order, the corresponding intervention(s) for the order may not be created.
FDA Determined
Cause 2		 Software design
Action Philips Medical Systems notified accounts by letter on October 21, 2009, of the release ICIP version D.03, which contains a software correction . A Philips representative will schedule the implementation of this upgrade. Please contact the Philips Customer Care Center with questions or concerns about this correction at 1-800-722-9377.
Quantity in Commerce 53 units
Distribution MD, RI, WV, and TX Australia Belgium Denmark France Italy Malaysia Singapore Spain Switzerland Taiwan United Arab Emirates United Kingdom and Ireland
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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