Class 2 Device Recall

• Date Initiated by Firm: September 27, 2002
• Date Posted: February 01, 2003
• Recall Status: Terminated on January 12, 2005
• Recall Number: Z-0526-03
• Recall Event ID: 25248
• 510(K)Number: K953910
• Product Classification: System, X-Ray, Mobile - Product Code IZL
• Product: Philips BV300 Mobile X-Ray System
• Code Information: Part numbers 9896 000 06801 and 9806 000 06802 with serial numbers: DBXXXX - all DBXXXX - all DDXXXX - all DEXXXX - all DG0001-DG0129 DH0001-DH0033 DJ0001 - DJ0152 DK0001 - DK 0076
• Recalling Firm/ Manufacturer: Philips Medical Systems; 22100 Bothell Everett Highway; Bothell WA 98041
• For Additional Information Contact: Sarah Baxter; 425-487-7665
• Manufacturer Reason for Recall: The C-bow support can bend and break allowing C-arm to fall from support
• FDA Determined Cause: Other
• Action: The firm issued a letter dated 9/27/02 to their customers. The letter advised of the problem and that a service representative will visit to inspect unit and correct.
• Quantity in Commerce: 229 devices
• Distribution: The firm distributed to hospitals, x-ray centers and medical centers throughout the U.S.
• 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 = IZL and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.