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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 Portalsee related information
Date Initiated by FirmJanuary 27, 2012
Date PostedFebruary 29, 2012
Recall Status1 Terminated 3 on February 25, 2021
Recall NumberZ-1125-2012
Recall Event ID 61043
510(K)NumberK003853 K110151 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductPhilips 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
ActionPhilips 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 Commerce25 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = LNH
510(K)s with Product Code = LNH
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