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U.S. Department of Health and Human Services

Class 3 Device Recall NanoMaxx ultrasound system

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 Class 3 Device Recall NanoMaxx ultrasound systemsee related information
Date Initiated by FirmAugust 13, 2010
Date PostedNovember 26, 2010
Recall Status1 Terminated 3 on July 21, 2011
Recall NumberZ-0478-2011
Recall Event ID 56428
510(K)NumberK092058 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
ProductThe software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The software is used with the SonoSite NanoMaxx ultrasound system.
Code Information Part code: P11111-35. Serial numbers: 03HQF4, 03HQF3, 03HQF6, 03HQCM, 03HPZK, 03HQ9X, 03H9C3, 03HKN6,   03HPQ9, 03H87H, 03HQ9M, 03HQ9Q, 03HQB2, 03HQB3, 03HQBB, 03HQBX,   03HQBY, 03HQBZ, 03HQC2, 03HQC3, 03HQC4, 03HQC5, 03HQC6, 03HQCC,   03HQCD, 03HQCF, 03HQCG, 03HQCH, 03HQCJ, 03HQCK, 03HQCN, 03HQCP,   03HQCX, 03HQD2, 03HQD3, 03HQD4, 03HQD5, 03HQD8, 03HQD9, 03HQDB,   03HQDD, 03HQDF, 03HQDG, 03HQDH, 03HQDK, 03HQDL, 03HQDN,   03HQDP, 03HQFL, 03HQ77, 03H16Q, 03HKM7, 03HQBH, 03HQD6, 03HQCL,   03HQ6M, 03HQFG, 03HQF5, 03HQB9, 03HQDC, 03HQDT, 03HQDX, 03HQF0,   03HQF2, 03HQF7, 03HPL9, 03HQD7, 03HQC0, and 03HQFJ.  
FEI Number 3002087856
Recalling Firm/
Manufacturer		 Sonosite, Inc.
21919 30th Dr Se
Bothell WA 98021-3904
For Additional Information Contact
425-951-1200
Manufacturer Reason
for Recall		Software ARM version 60.80.101.025 (referred to as Nano1.0.5) on the NanoMaxx ultrasound system results in errors when the "print" command is selected. As a result, the displayed MI or TI values may be incorrect.
FDA Determined
Cause 2		Software design
ActionSonosite issued Urgent Medical Device Correction letters dated August 9, 2010 to consignees. Consignees were advised of the software problem and given directions to verify the software version they are using. They are advised to contact SonoSite at 877-657-8118 to obtain a free software upgrade.
Quantity in Commerce69
DistributionWorldwide Distribution: USA and to the countries of Australia, Great Britain, India, Israel, the Netherlands, New Zealand, Norway, and Spain.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYN
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