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Class 3 Device Recall NanoMaxx ultrasound system |
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Date Initiated by Firm |
August 13, 2010 |
Date Posted |
November 26, 2010 |
Recall Status1 |
Terminated 3 on July 21, 2011 |
Recall Number |
Z-0478-2011 |
Recall Event ID |
56428 |
510(K)Number |
K092058
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Product Classification |
System, imaging, pulsed doppler, ultrasonic - Product Code IYN
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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 WA 98021-3904
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For Additional Information Contact |
425-951-1200
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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.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = IYN and Original Applicant = SONOSITE,INC.
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