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Class 2 Device Recall Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal XRay System |
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Date Initiated by Firm |
April 18, 2011 |
Date Posted |
July 08, 2011 |
Recall Status1 |
Terminated 3 on February 15, 2013 |
Recall Number |
Z-2765-2011 |
Recall Event ID |
58566 |
510(K)Number |
K912470
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Product Classification |
System, x-ray, fluoroscopic image-intensified - Product Code JAA
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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 MA 01810
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For Additional Information Contact |
978-687-1501
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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
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = JAA and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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