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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
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/
Philips Medical Systems Gmbh, DMC
Development and Manufacturing Ctr.
Roentgenstrasse 24
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.