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U.S. Department of Health and Human Services

Class 2 Device Recall LAP Surgical Transducer

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 Class 2 Recall
LAP Surgical Transducer
see related information
Date Posted October 01, 2010
Recall Status1 Terminated on October 05, 2010
Recall Number Z-2654-2010
Recall Event ID 49387
Premarket Notification
510(K) Number
K043559 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultrasound system. The LAP Transducer label is labeled in part: "MicroMaxx LAP...Manufactured for SonoSite, Inc., Bothell, WA 98021".
Code Information 16 devices are identified with Serial Numbers: 038VWM, 038FK1, 0379P6, 038G67, 038VWK, 038192, 0379P1, 0379P2, 038FJZ, 038FJW, 0379P0, 0379P5, 037WMJ, 038VWP, 037XT6, and 038153.
Recalling Firm/
Manufacturer
Sonosite, Inc.
21919 30th Dr Se
Bothell, Washington 98021-3904
Manufacturer Reason
for Recall
Sterilization of the SonoSite LAP surgical Transducer with the Sterrad NX System may result in damage to the transducer.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action On November 2, 2007, SonoSite sent out the Important Information Regarding Sterrad NX Incompatibility letter and the Technical Bulletin 005/07 Rev A to their consignees. The letter advises the consignees that SonoSite has recently found that sterilization of the SonoSite SLT and LAP surgical ultrasound transducers with the Sterrad NX system may result in damage to the transducer. The Technical Bulletin 005/07 Rev B dated November 2, 2007 informs the consignees that the damage has been observed primarily on the circuit board in the transducer connector, and cable and laparoscope damage may also be occurring. All damages have occurred after processing using the Sterrad NX systems in its "Advanced" cycle and the potential damage from the use of "normal" cycle is being evaluated by the firm. Consignees should call the Technical Support at 1-425-951-1330 or 1-877-657-8118 or e-mail to service@sonosite.com for any questions regarding the recall.
Quantity in Commerce 16 units
Distribution Devices were distributed to medical centers and hospitals in AR, CA, IN, KS, MA, MD, MI, NC, NE, NJ, NV, OH, SC, TN, TX, WI, Washington DC and to FOREIGN COUNTRIES Australia, China, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Korea, Republic of, Libyan Arab Jamahiriya, Mexico, Spain, United Arab Emirates, United Kingdom, and United States.
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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