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U.S. Department of Health and Human Services

Class 2 Device Recall ISP DX/HX/EX, ISP DX/HX/EX Upgrade, ISP DX/HX/EX Demo, ISP IX

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  Class 2 Device Recall ISP DX/HX/EX, ISP DX/HX/EX Upgrade, ISP DX/HX/EX Demo, ISP IX see related information
Date Initiated by Firm November 09, 2014
Date Posted December 01, 2014
Recall Status1 Terminated 3 on September 14, 2015
Recall Number Z-0473-2015
Recall Event ID 69793
510(K)Number K132524  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product IntelliSpace Portal DX/HX/EX model number: 881001
IntelliSpace Portal DX/HX/EX Upgrade model number: 881011
IntelliSpace Portal DX/HX/EX Demo model number: 881012
IntelliSpace Portal IX model number; 881030
System, x-ray, tomography, computed
Code Information IntelliSpace Portal DX/HX/EX: 96027,96029,96025,96030,96031,85479,79935, 98087,85175,96024,106013,450003, 950002, 950003,35009,35030,870056, 550012, 85081, 97069, 45001985333, 35036, and 85382. IntelliSpace Portal DX/HX/EX Upgrade: 950100, 55003, and 81178. IntelliSpace Portal DX/HX/EX Demo: 85451 and 87290. IntelliSpace Portal IX: 50306, 40219, and 40368.  IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mr. Daniel R. Brown
440-483-2219
Manufacturer Reason
for Recall		 Software defect. In certain circumstances, the application may display incorrect measurements of cardiac and aortic anatomy used to select and size the Transcatheter heart valve (THV) to be implanted .
FDA Determined
Cause 2		 Software design
Action Consignees were notified of the Field Safety Notice via certified mail.
Quantity in Commerce 32
Distribution Worldwide Distribution: US Distribution in states of: FL, NC, and VT; and the countries of Argentina, Austria, Belgium, Canada, Denmark, France, India, Italy, Japan, Netherlands, United Kingdom, and Vietnam.
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 = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS
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