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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Intellispace Portal

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 Class 2 Recall
Philips Intellispace Portal
see related information
Date Posted February 29, 2012
Recall Status1 Open
Recall Number Z-1125-2012
Recall Event ID 61043
Premarket Notification
510(K) Numbers
K003853  K110151 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic information/data Model: 881001. Indicated for use as a diagnostic device.
Code Information Software release 4.0.0
Recalling Firm/
Manufacturer
Philips Medical Systems Nederlands
Veenpluis 4-6
Best
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
There maybe incorrect values in the diffusion/perfusion maps.
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips issued URGENT - Medical Device Correction Notifications, dated January 20, 2012. The letter identified the affected product, all Intellispace Portal with software release 4.0.0 Installed, and gave a description of the problem. Users were provided with the actions to be taken prior to the software upgrade( to version 4.0.1). Users are to follow the instructions provided in order to generate maps with the correct values and to make sure that the setting is correct before using the generated data. Philips will contact customers in order to install the update free of charge. Customers should contact their local Philips representative at 866-767-2822.
Quantity in Commerce 25 units
Distribution Worldwide Distribution -- US, including states of IN and TX, and countries of Australia, Austria, Czech, Denmark, France, Germany, Indonesia, Netherlands, Poland, Spain, and Switzerland.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = PHILIPS HEALTHCARE
510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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