The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The software is used with the SonoSite NanoMaxx u
FDA device recall Z-0478-2011 · posted 2010-11-26 · Terminated
Recall details
- Recalling firm
- Sonosite, Inc.
- 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.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 69
- Distribution
- Worldwide Distribution: USA and to the countries of Australia, Great Britain, India, Israel, the Netherlands, New Zealand, Norway, and Spain.
- Date initiated
- 2010-08-13
- Date posted
- 2010-11-26
- Date terminated
- 2011-07-21
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM (K092058) | Sonosite,Inc. | 2009-10-02 |