FDA Medical Device Recalls (openFDA)
Sonosite, Inc.: 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.
- Recall number
- Z-0478-2011
- Recalling firm
- Sonosite, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2010-08-13
- Posted
- 2010-11-26
- Terminated
- 2011-07-21
- Reason
- 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.
- Root cause
- 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
- 69
- Distribution
- Worldwide Distribution: USA and to the countries of Australia, Great Britain, India, Israel, the Netherlands, New Zealand, Norway, and Spain.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K092058"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3002087856
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28