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 Philips Easy Diagnost Eleva DRF

  • 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 Philips Easy Diagnost Eleva DRF see related information
Date Initiated by Firm March 09, 2012
Date Posted March 23, 2012
Recall Status1 Terminated 3 on May 23, 2013
Recall Number Z-1283-2012
Recall Event ID 61365
510(K)Number K031535  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product Philips Easy Diagnost Eleva DRF, Software release 4.0
Fluoroscopic image-intensified Stationary X-Ray System.
Code Information Software release 4.0 
Recalling Firm/
Manufacturer		 Philips Medical Systems Gmbh, DMC
Development and Manufacturing Ctr.
Roentgenstrasse 24
Hamburg Germany
Manufacturer Reason
for Recall		 Underexposed image due to lag in switching between auxiliaries
FDA Determined
Cause 2		 Software design
Action Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated February 27, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The firm provided a work around for customers to use until a software update can be installed. Customers should contact their local Philips representative for questions regarding this notice.
Quantity in Commerce 88 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Australia, Germany, Indonesia, Malaysia, Saudi-Arabia, Singapore, and Thailand.
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 = JAA and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
-
-