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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Easy Diagnost Eleva DRF

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 Class 2 Recall
Philips Easy Diagnost Eleva DRF
see related information
Date Posted March 23, 2012
Recall Status1 Terminated on May 23, 2013
Recall Number Z-1283-2012
Recall Event ID 61365
Premarket Notification
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
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Underexposed image due to lag in switching between auxiliaries
FDA Determined
Cause 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
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