Class 2 Device Recall Compumedics

• Date Initiated by Firm: February 24, 2005
• Date Posted: March 24, 2005
• Recall Status: Terminated on December 07, 2007
• Recall Number: Z-0652-05
• Recall Event ID: 31197
• 510(K)Number: K000068
• Product Classification: Full-Montage Standard Electroencephalograph - Product Code GWQ
• Product: Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia
• Code Information: All codes
• FEI Number: 3002716534
• Recalling Firm/ Manufacturer: Compumedics Usa, Ltd; 7850 Paseo Del Norte; El Paso TX 79912
• Manufacturer Reason for Recall: Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin.
• FDA Determined Cause: Other
• Action: The firm initiated the recall on February 24, 2005 via letter with return response post card.
• Quantity in Commerce: 1376 units
• Distribution: Product was distributed nationwide and to the following foreign countries: Australia, Canada, Greece, Hong Kong, Hungary, India, Iran, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pillippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, and the United Kingdom.
• 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 = GWQ