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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal XRay System

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 Class 2 Recall
Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal XRay System
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Date Posted July 08, 2011
Recall Status1 Terminated on February 15, 2013
Recall Number Z-2765-2011
Recall Event ID 58566
Premarket Notification
510(K) Number
K912470 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System The Diagnost is a multifunctional, universal X~ray system with remote controlled facilities. Routine examinations that can be performed with the Diagnost include: Gastro-Intestinal examination, Urograpy, Bronchography, Arthrography, Hysterography, Myelography, Lymphography, Skeletal radiography, Tomography and Venography/phlebography. Special procedures that require subtracted and non subtracted digital imaging include: Angiography, Peripheral angiography (bolus chasing) and Vascular and non~vascular interventional procedures
Code Information All serial numbers
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Manufacturer Reason
for Recall
Updated Instructions For Use: During an examination where the patient is positioned on a -rotatable- chair with knees pointed to the rear of the system, the patients lower legs or ankles may be injured/broken
FDA Determined
Cause 2
DESIGN: Device Design
Action Philips Healthcare notified accounts by letter on April 18, 2011. The letter advised users of the problem and provided updated instructions for proper placement of the patient during the examination. An Updated Instruction For Use was provided. For further information and support customers were instructed to contact the Philips representative.
Quantity in Commerce 52 units
Distribution Nationwide Distribution
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, INC.
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