Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall ISP DX/HX/EX, ISP DX/HX/EX Upgrade, ISP DX/HX/EX Demo, ISP IXsee related information
Date Initiated by FirmNovember 09, 2014
Date PostedDecember 01, 2014
Recall Status1 Terminated 3 on September 14, 2015
Recall NumberZ-0473-2015
Recall Event ID 69793
510(K)NumberK132524 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductIntelliSpace 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 ContactMr. 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
ActionConsignees were notified of the Field Safety Notice via certified mail.
Quantity in Commerce32
DistributionWorldwide 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 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 = JAK
-
-