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U.S. Department of Health and Human Services

Class 2 Device Recall MicroMaxx LAP Transducer

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 Class 2 Recall
MicroMaxx LAP Transducer
see related information
Date Posted March 29, 2007
Recall Status1 Terminated on June 01, 2007
Recall Number Z-0661-2007
Recall Event ID 37452
Premarket Notification
510(K) Numbers
K043559  K053069 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer
Code Information Serial Numbers: 037XT6, 0379P5, 037WMJ, 0379P1, 0379P2, 0379P0 Part Number: P05507-10
Recalling Firm/
Manufacturer
Sonosite, Inc.
21919 30th Dr Se
Bothell, Washington 98021-3904
For Additional Information Contact Daina L. Graham
425-951-1275
Manufacturer Reason
for Recall
Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db.
FDA Determined
Cause 2
DESIGN: Device Design
Action On 2/5/2007 firm sent by FED-Ex notification letters to firm representatives. Representatives began hand delivery of recall letter to consignees and retrieval of LAP transducer for return delivery to firm. The letter advised customers that the LAP transducer exceeded the limits specified for radio-frequency emissions. The firm also advised that exceeding the limit may cause the LAP transducer to interfere with surrounding equipment that may be susceptible to radiated emissions and cause surrounding equipment to not perform as expected.
Quantity in Commerce 6 Devices
Distribution Distribution to USA (Tennessee & Ohio), France, Korea, and Germany.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = SONOSITE,INC.
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