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U.S. Department of Health and Human Services

Class 2 Device Recall PowerPark

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 Class 2 Recall
PowerPark
see related information
Date Posted August 02, 2010
Recall Status1 Terminated on April 18, 2011
Recall Number Z-2116-2010
Recall Event ID 55874
Premarket Notification
510(K) Numbers
K053069  K082098  K092058 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted assembly (P12822) and a docking assembly (P12834). The stand mounted assembly is mounted to the V or H Universal stand and the docking assembly is plugged into a wall circuit. It provides a docking and charging station for the V and H Universal Stands. The product marketing brochure labeled in part: "SonoSite Ltd...21919 30th Drive SE... Bothell, WA 98021, USA".
Code Information Serial numbers for the Stand Mounted Assembly (P12822): 03J5RJ; 03J5G2; 03J5RX; 03J5GC; 03J5FN; 03J5RH; 03J5BL; 03J5FF; 03J5D1; 03J5CV; 03J5D0; 03J5GN; 03J4RB; 03J5D4; 03J5G9; 03HPVK; 03J5T3; 03HPVF; 03J4RD; 03J5D3; 03J5G1; 03J5FD; 03J5G5; 03J5CZ; 03J4RC; and 03J4RG. Serial numbers for the Docking Assembly (P12834): 03J4R0; 03J4R1; 03J5CY; 03J4R4; 03J520; 03J5FK; 03J5G7; 03J5G8; 03J51R; 03J5BF; 03J5BH; 03J4R6; 03J5GJ; 03J5GG; 03J5FL; 3J4RX; 03J5GK; 03J0GR; 03J5RR; 03J5G6; 03J5RC; 03J5FJ; 03J5G5; 03J5RV; 03J5GH; and 03J5RF.
Recalling Firm/
Manufacturer
Sonosite, Inc.
21919 30th Dr Se
Bothell, Washington 98021-3904
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action On 05/27/10, SonoSite began contacting their consignees by telephone. On 06/01/10, SonoSite sent out the URGENT-MEDICAL DEVICE RECALL letter to their consignees. The letter describes the recall product as SonoSite PowerPark. Customers should call the Technical Support at 1-877-657-8118 or e-mail to service@sonosite.com for any questions regarding the recall. The letter instructs consignees to stop using the PowerPark immediately and return the product back to SonoSite in exchange for a full refund. The consignees will be contacted by the firm's Sales Representative and/or Clinical Applications Specialist to schedule an appointment to retrieve the device and deliver a refund.
Quantity in Commerce 26
Distribution Worldwide Distribution -- USA, including states of GA, NM, PA, TX, VA, and WA and country of Australia.
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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