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U.S. Department of Health and Human Services

Class 2 Device Recall Philips EasyVision MM workstation with software

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 Class 2 Recall
Philips EasyVision MM workstation with software
see related information
Date Posted November 18, 2010
Recall Status1 Terminated on November 19, 2010
Recall Number Z-0412-2011
Recall Event ID 52108
Premarket Notification
510(K) Numbers
K051315  K063093 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Philips EasyVision MM workstation with software R10.2 and R11.1 The EasyVision MM Workstation is intended for the manipulation and display of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. Device options enable mammography reading, teleradiology, fast demonstration, 3D, etc. Device accessories enable orthopedic pre-operative planning; angiography/cardiology imaging capabilities; and bone densitometry capabilities. Typical users are trained professionals such as physicians, radiologists, nurses, medical technicians and assistants.
Code Information Site Numbers: 50310, 84026, 103216, 105518, 505284, 505973, 506122, 533261, 536204, 537203, and 557450.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
For Additional Information Contact Philips Healthcare Call Center
800-722-9377
Manufacturer Reason
for Recall
Review by firm of Philips EasyVision MM workstations found that to assure compliance with 21 CFR 900.12(c)(5) corrected software was needed so that all sites are in compliance.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Philips Medical Systems North America Co. sent an URGENT-Field Safety Notice dated January 30, 2009, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were advised to ascertain the quality of a hard or soft copy explicity before further distribution to make sure that no part of the tissue is covered by image identification information. Philips will issue the Field Change Order (FCO) 83000129 and release a level on EasyVision MM R10.2 L6 and EasyVision MM R11.1 L3 to resolve the issue. Customers could contact Philips Healthcare Call Center at 1-800-722-9377, #2, #3 and Reference FCO 83000129 for any questions.
Quantity in Commerce 11 units in US
Distribution Nationwide Distribution including DC, FL, MI, MO, NM, NY, OH, AND TX
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 = LLZ and Original Applicant = SECTRA IMTEC AB
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