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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 Device Recall Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal XRay System see related information
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  
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 MA 01810
For Additional Information Contact
978-687-1501
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		 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 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 and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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