Class 2 Device Recall Philips Easy Diagnost Eleva DRF

• Date Initiated by Firm: March 09, 2012
• Date Posted: March 23, 2012
• Recall Status: Terminated 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: 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