Company: Biosound Esaote, Inc
Date of Enforcement Report: 9/7/05
Class:II
PRODUCT
a) MyLab30CV Ultrasound Imaging System; model 9807300000,
Recall # Z-1401-05;
b) MyLab30CV Ultrasound Imaging System; model 9807300001,
Recall # Z-1402-05;
c) MyLab25 Ultrasound Imaging System; model 9807300002,
Recall # Z-1403-05
REASON
Data maybe corrupted upon re-opening archived files.
CODE
a) All units using software version 3.02:
Serial numbers 53, 58, 60, 67, 70,
72, 73, 75 and 79;
b) 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;
c) All units using software version 3.02:
Serial numbers 530-539.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biosound Esaote, Inc., Indianapolis, IN, by letters dated May 2, 2005, May 6, May 9 and May 13, 2005.
Manufacturer: Esaote Biomedica S.P.A., Firenze, Italy. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
195 units
DISTRIBUTION
Nationwide, Canada and Venezuela
