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 MultiDiagnost Eleva with Flat Detector (MDE FD)

  • 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 MultiDiagnost Eleva with Flat Detector (MDE FD) see related information
Date Initiated by Firm December 30, 2008
Date Posted September 25, 2009
Recall Status1 Terminated 3 on September 28, 2010
Recall Number Z-0623-2009
Recall Event ID 50748
510(K)Number K050151  
Product Classification Stationary X-Ray System - Product Code KPR
Product Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher

Used for general R/F, fluoroscopy, radiography, and angiography examinations.
Code Information software version 4.3.1 or higher.  Units are identified with Site Numbers:  538440, 542581, 543228, 543846, 543886, 544123, 544124, 544904, 545113, 545114, 548112, 551714, 553435, 553838, 554283, 554284, 554633, 554640, 556369, 557258, 41445127, 41445131, 41445800, 41455927, 41643223, 41849575, 42549980, 42799914, and 41445927.  
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact
425-487-7602
Manufacturer Reason
for Recall		 System fails to meet requirements when it is used at kV levels greater than 115 kV at certain frame rates and in certain acquisition modes, as grid switch leakage may occur.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action A Customer Notification letter describing the failure, the means, by which a customer can prevent the failure mode from occurring, and actions planned by Philips to correct the problem were sent to all users of the affected systems. Philips will modify the system software and will be installed at no cost to the customer.
Quantity in Commerce 30 systems
Distribution Nationwide distribution including states CA, CO, IA, ID, KS, MN, NC, NJ, NY, OH, SC, TX, UT, VA, and WI.
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 = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
-
-