Class 3 Device Recall MX8000 Computed Tomography Xray Scanning System

• Date Initiated by Firm: April 02, 2003
• Date Posted: May 15, 2003
• Recall Status: Terminated on December 01, 2003
• Recall Number: Z-0836-03
• Recall Event ID: 26080
• 510(K)Number: k010817
• Product Classification: System, X-Ray, Tomography, Computed - Product Code JAK
• Product: Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software.
• Code Information: Serial Numbers: 8008 through 8069.
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Highland Heights OH 44143
• Manufacturer Reason for Recall: Patient images may be incorrectly stored in the archive directory of a different patient.
• FDA Determined Cause: Other
• Action: The firm mailed a ''Product Safety Notification'', dated 4/2/2003, to all affected user sites.
• Quantity in Commerce: 50 installed units (24 domestic)
• Distribution: The units were installed in medical facilities located nationwide, and in the following foreign countries: China, Belgium, France, Austria, Germany, Italy, Netherlands, Australia, Israel, Spain, Denmark, Singapore, Switzerland, Russia, South Korea, Canada, United Kingdom, South Africa, Sweden, Japan, Brazil.
• 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 and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.