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U.S. Department of Health and Human Services

Class 2 Device Recall BuckyDiagnost

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  Class 2 Device Recall BuckyDiagnost see related information
Date Initiated by Firm January 21, 2010
Date Posting Updated March 23, 2010
Recall Status1 Terminated 3 on January 25, 2011
Recall Number Z-0848-2010
Recall Event ID 54641
510(K)Number K945278  
Product Classification Stationary X-Ray System - Product Code KPR
Product BuckyDiagnost. General Radiography and Tomography examination of patients in supine, seated, or standing positions.
Code Information Site Numbers:

545896, 17673, 62929, 102578, 104781, 250137, 250294, 505841, 538513, 539863, 542610, 545089, 548438, 557949, 43717870, and 44329671.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Philips Healthcare Call Center
800-722-9377 Ext. 5
Manufacturer Reason
for Recall
Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
Action Urgent - Field Safety Notice letters, dated January 20 & 21, 2010, were sent to customers. The letter identified the affected products, gave a description of the problem & the hazard involved, stated how to identify affected products, actions to be taken by the customer or user, and actions planned by the firm. Customers are to make sure that the relevant safety precautions are observed and check their operators console (EEC) if the labeling is present as shown in the drawing. If the labeling is missing, a Philips rep should be contacted. For further information or support concerning the issue, a Philips rep should be contacted at 800-722-9377.
Quantity in Commerce 16 units
Distribution Devices were distributed through out the US in the following states: AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, WI, and WY.
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 = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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