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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 Device Recall MicroMaxx LAP Transducer see related information
Date Initiated by Firm February 05, 2007
Date Posted March 29, 2007
Recall Status1 Terminated 3 on June 01, 2007
Recall Number Z-0661-2007
Recall Event ID 37452
510(K)Number K043559  K053069  
Product Classification Laparoscopic Ultrasound Transducer - 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 WA 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		 Other
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 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 = SONOSITE,INC.
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