07

Sep

2005

Inc Class II Biosound Esaote

0

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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