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U.S. Department of Health and Human Services

Class 2 Device Recall Philips MultiDiagnost Eleva IITV

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 Class 2 Recall
Philips MultiDiagnost Eleva IITV
see related information
Date Posted February 08, 2012
Recall Status1 Open
Recall Number Z-0985-2012
Recall Event ID 60898
Premarket Notification
510(K) Number
K023441 
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 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
Manufacturer Reason
for Recall
Incorrect Skin Dose calculation. AKR (Air Kerma Rate) displayed and stored in patient records is too low
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips Healthcare issued a mandatory Urgent Field Safety Noticedated October 3, 2011 to all affected customers. The letter identifies the affected product, problem description, hazard involved, action to be taken by customer/user and actions planned by Philips to correct the problem. The letter provide important information for the continued safe and proper use of the equipment. The letter instructs customers to review the following information with all members of their staff who need to be aware of the contents of this communication and retain a copy with the equipment Instruction for Use. For further information or support concerning this issue contact your local Philips representative at 866-767-2822.
Quantity in Commerce 10 units (US)
Distribution Worldwide Distribution - USA (nationwide) including the states of CA, IL, OH, SD, TX, WY and the countries of: Australia, Austria, Canada, Egypt, Germany, mexico, Turkey and UK
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
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