Class 2 Device Recall BV25

• Date Initiated by Firm: July 20, 2004
• Date Posted: September 15, 2004
• Recall Status: Terminated on February 09, 2006
• Recall Number: Z-1454-04
• Recall Event ID: 29855
• 510(K)Number: K921255
• Product Classification: System, X-Ray, Mobile - Product Code IZL
• Product: BV 25 Gold Mobile X-Ray System
• Code Information: see site numbers listed above for BV 25
• Recalling Firm/ Manufacturer: Philips Medical Systems Sales & Service Region No. America; 22100 Bothell Everett Hwy; Bothell WA 98021
• For Additional Information Contact: Sarah Baxter; 425-487-7665
• Manufacturer Reason for Recall: Potential for c-arm to move due to loose screws
• FDA Determined Cause: Other
• Action: Beginning on 7/20/04 the firm sent a letter dated 7/19/04 via certified mail. Mailing was completed 7/27/04. The letter advises customers of the problem, advises how to determine of the screws are loose, and if so to contact Philips. The letter also advises that a respresentative will visit each consignee to inspect and correct the problem.
• Quantity in Commerce: 1900 total devices (includes BV25, BV 25 Gold, BV26, BV29, BV212
• Distribution: The units are distributed to hospitals 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