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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Bucky Diagnost FS

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  Class 2 Device Recall Philips Bucky Diagnost FS see related information
Date Initiated by Firm November 18, 2003
Date Posted December 24, 2003
Recall Status1 Terminated 3 on April 11, 2005
Recall Number Z-0268-04
Recall Event ID 27827
510(K)Number K945278  
Product Classification System, X-Ray, Stationary - Product Code KPR
Product Bucky Diagnost FS Part number 9890-010-83651
Code Information Site numbers: 504495, 105355, 104447. The firm uses site numbers instead of serial numbers.
Recalling Firm/
Manufacturer		 Philips Medical Systems Sales & Service Region No. America
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information Contact
425-487-7000
Manufacturer Reason
for Recall		 Support chain attachment on the Bucky carriage may fail and cause the counter weights or X-ray tube to fall.
FDA Determined
Cause 2		 Other
Action The firm mailed a letter to their customers on November 18, 2003 stating upgrades will begin November 14, 2003.
Quantity in Commerce 3 units
Distribution The firm distributed to three medical facilities in Florida, New York and California.
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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