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U.S. Department of Health and Human Services

Class 2 Device Recall EasyDiagnost Eleva

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 Class 2 Recall
EasyDiagnost Eleva
see related information
Date Posted August 10, 2010
Recall Status1 Terminated on October 27, 2010
Recall Number Z-2194-2010
Recall Event ID 48998
Premarket Notification
510(K) Number
K031535 
Product Classification System, X-Ray, Stationary - Product Code KPR
Product The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system.
Code Information Serial Numbers 353320, 362600, 362601, 364209, 364210, 375245 and 375850.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
Manufacturer Reason
for Recall
Potential for bright artifacts to appear on the patient image from a previous exposure.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action On July 9, 2008, Philip Medical System began sending out the URGENT-Device Correction letter to their consignees. This letter describes the recalled product as EasyDiagnost Eleva with DRF system with SW release 1.0. The firm informs the consignees that under special circumstances there is a small possibility that bright artifacts appear on a patient image from a previous exposure. The consignees are advised to take care about the X-ray field limitation. If the detector is not affected by direct radiation, no problem will occur. If direct radiation reaches the detector, the collimation should not be too tight, such that the area of direct radiation is larger than 1.2 inch x 1.2 inch (or 30 mm x 30 mm). The minimum area is needed to detect and prevent memory artifacts. The firm will upgrade any affected products with the Field Change Order (FCO)70600031 and it will be implemented before the end of December 2008. The upgrade software is 1.0.3. The correction would be free of charge and the consignees should contact Philips Call Center at 800-772-9377, #5, #2.
Quantity in Commerce 7
Distribution Product was distributed in AZ, CA, FL and WA.
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 = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
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