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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 Systemsee related information
Date Initiated by FirmApril 18, 2011
Date PostedJuly 08, 2011
Recall Status1 Terminated 3 on February 15, 2013
Recall NumberZ-2765-2011
Recall Event ID 58566
510(K)NumberK912470 
Product Classification System, x-ray, fluoroscopic image-intensified - Product Code JAA
ProductPhilips 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
FEI Number 1218950
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
ActionPhilips 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 Commerce52 units
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAA
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