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.
This recall has been terminated (originally issued November 26, 2010).
- Company
- Sonosite, Inc.
- Recall Initiated
- August 13, 2010
- Posted
- November 26, 2010
- Terminated
- July 21, 2011
- Recall Number
- Z-0478-2011
- Quantity
- 69
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution: USA and to the countries of Australia, Great Britain, India, Israel, the Netherlands, New Zealand, Norway, and Spain.
Lot / Code Info
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.
Root Cause
Software design
Action Taken
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.