• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall NanoMaxx ultrasound system

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 3 Recall
NanoMaxx ultrasound system
see related information
Date Posted November 26, 2010
Recall Status1 Terminated on July 21, 2011
Recall Number Z-0478-2011
Recall Event ID 56428
Premarket Notification
510(K) Number
K092058 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product The 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.
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
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
DESIGN: Software Design
Action Sonosite 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 Commerce 69
Distribution Worldwide Distribution: USA and to the countries of Australia, Great Britain, India, Israel, the Netherlands, New Zealand, Norway, and Spain.
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.
-
-