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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 Device Recall Philips Intellispace Portal see related information
Date Initiated by Firm January 27, 2012
Date Posted February 29, 2012
Recall Status1 Terminated 3 on February 25, 2021
Recall Number Z-1125-2012
Recall Event ID 61043
510(K)Number K110151  K003853  
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 Netherlands
Manufacturer Reason
for Recall		 There maybe incorrect values in the diffusion/perfusion maps.
FDA Determined
Cause 2		 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 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 = 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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