Class 2 Device Recall MX8000 Dualv. EXP

• Date Initiated by Firm: March 16, 2015
• Date Posted: May 22, 2015
• Recall Status: Terminated on February 22, 2017
• Recall Number: Z-1647-2015
• Recall Event ID: 71177
• 510(K)Number: K010817
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
• Code Information: MX8000 Dual v. EXP: System Code #, 728130, Serial #, 8107, 8128, 8152, 8157, 8171, 8212, 8236, 8245, 8263, 8320 & 8357.
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: Mr. Yuchol Kim; 440-483-2997
• Manufacturer Reason for Recall: The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
• FDA Determined Cause: Employee error
• Action: On 3-18-2015 the firm sent Urgent Field Safety Notices to their customers.
• Quantity in Commerce: 153 units total
• Distribution: Distributed in China.
• 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