Class 2 Device Recall Philips brand MX8000 IDT CT Scanner System

• Date Initiated by Firm: March 08, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on October 29, 2008
• Recall Number: Z-0786-04
• Recall Event ID: 27979
• 510(K)Number: K012009
• Product Classification: System, X-Ray, Tomography, Computed - Product Code JAK
• Product: Philips MX8000 IDT CT Scanner System, 10 & 16 slice images.
• Code Information: Serial Numbers: 2501 to 2554; 3006; 3008 to 3337.
• FEI Number: 1525965
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: 440-483-3521
• Manufacturer Reason for Recall: The CT couch may move downward to its lower limit without command.
• FDA Determined Cause: Other
• Action: The firm contacted their Field Service Personnel by letter on 3/8/2004. The letter instructs the field personnel to immediately install the corrective firmware kits (from Siemens) on all affected units in the field.
• Quantity in Commerce: 385 units
• Distribution: The systems were installed at medical facilities located nationwide and worldwide.
• 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 = JAK