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U.S. Department of Health and Human Services

Class 2 Device Recall Philips MultiDiagnost Eleva FD (MDFD)

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 Class 2 Recall
Philips MultiDiagnost Eleva FD (MDFD)
see related information
Date Posted February 02, 2012
Recall Status1 Open
Recall Number Z-0936-2012
Recall Event ID 60936
Premarket Notification
510(K) Number
K050151 
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 Product Code 708037 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.
Code Information Software release: PBL 6.1.1
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The skin dose and skin dose rate values are calculated using an incorrect point of reference. Therefore, the AKR as displayed and stored in patient records is too low, although the dose as received by the patient is not affected.
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips Healthcare issued on January 9, 2012 a mandatory Field Safety Notice to all affected customers. The letter identified the affected product, problem description, hazard involved and actions that should be taken by the customer/user. The letter contains important information for the continued safe and proper use of the equipment. Customers were instructed to review the following information with all members of there staff and retain a copy with the equipment "Instruction for Use". For information or support concerning this notice contact your local Philips representative 866-767-2822.
Quantity in Commerce 28 units (US)
Distribution Worldwide Distribution - Nationwide Distribution (USA) including the states of AR, AZ, CA, CO, FL, IA, KS, LA, MI, MO, NC, NY, OH, PA, TX, VA, VT, WA and WV
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 = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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