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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 Device Recall Philips MultiDiagnost Eleva FD (MDFD) see related information
Date Initiated by Firm January 09, 2012
Date Posted February 02, 2012
Recall Status1 Terminated 3 on February 13, 2017
Recall Number Z-0936-2012
Recall Event ID 60936
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 MA 01810
For Additional Information Contact
978-687-1501
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		 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 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 = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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