Class 2 Device Recall

• Date Initiated by Firm: August 10, 2003
• Date Posted: September 11, 2003
• Recall Status: Terminated on January 13, 2005
• Recall Number: Z-1213-03
• Recall Event ID: 27013
• 510(K)Number: K912470
• Product Classification: Table, Radiographic, Non-Tilting, Powered - Product Code IZZ
• Product: Diagnost 97
• Code Information: See list for Diagnost 96
• 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: Potential for table to move by itself
• FDA Determined Cause: Other
• Action: The firm issued a letter dated 8/10/03 informing the consignees of the error and advising that a service employee will be visiting each site for software upgrade.
• Quantity in Commerce: see above
• Distribution: The firm distributed devices to hospitals and medical centers located 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 = IZZ and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.