Class 2 Device Recall MyLab

• Date Initiated by Firm: May 06, 2005
• Date Posted: August 25, 2005
• Recall Status: Terminated on October 25, 2005
• Recall Number: Z-1403-05
• Recall Event ID: 32019
• 510(K)Number: K040596
• Product Classification: System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
• Product: MyLab25 Ultrasound Imaging System; Model 9807300002.
• Code Information: All units using software version 3.02: Serial numbers 530-539.
• Recalling Firm/ Manufacturer: Biosound Esaote, Inc.; 8000 Castleway Dr; Indianapolis IN 46250-1943
• For Additional Information Contact: Carrie Graham; 866-359-4310
• Manufacturer Reason for Recall: Data may be corrupted upon re-opening archived files.
• FDA Determined Cause: Other
• Action: U.S. distributors were notified via recall letter dated 5/2/05 and U.S. customers were notified via letter dated 5/6/05. Canadian customer were notified via letter dated 5/13/05 and Puerto Rico distributor and customers were ntofied on 5/9/05. The firm is installing new software in the field.
• Quantity in Commerce: 10
• Distribution: Nationwide, Canada and Venezuela.
• 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 = IYN and Original Applicant = ESAOTE S.P.A.