Class 2 Device Recall Philips Bucky Diagnost FS

• Date Initiated by Firm: November 18, 2003
• Date Posted: December 24, 2003
• Recall Status: Terminated 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: 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