Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall My Lab

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall My Lab see related information
Date Initiated by Firm May 06, 2005
Date Posted August 25, 2005
Recall Status1 Terminated 3 on October 25, 2005
Recall Number Z-1402-05
Recall Event ID 32019
510(K)Number K040596  
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product MyLab30CV Ultrasound Imaging System; model 9807300001.
Code Information All units using software version 3.02: Serial numbers 102-112, 114-120, 122, 134-141, 149-167, 169, 172, 279-190, 196-210, 212-218, 220-222, 224-226, 228-247, 251-295, 317. 319. 322-329, 339, 340, 367, 368, 370-387, 393, 400, 410, 414-432, 478, 480-483, 485-488, 509-522 and 569-582.
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 176
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.
-
-