Date Initiated by Firm |
May 06, 2005 |
Date Posted |
August 25, 2005 |
Recall Status1 |
Terminated 3 on October 25, 2005 |
Recall Number |
Z-1401-05 |
Recall Event ID |
32019 |
510(K)Number |
K040596
|
Product Classification |
System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
|
Product |
MyLab30CV Ultrasound Imaging System; model 9807300000. |
Code Information |
All units using software version 3.02: Serial numbers 53, 58, 60, 67, 70, 72, 73, 75 and 79. |
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 2 |
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 |
9 |
Distribution |
Nationwide, Canada and Venezuela. |
Total Product Life Cycle |
TPLC Device Report
|
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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.
|