2010 Product Recalls

Acuson CV70 Ultrasound systems Ultrasonic Pulsed echo/doppler imaging system with Software revisions less than 4.0.0b, material number 784539, 7848521, and 7848547. Is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms.

System may either display incorrect mechanical and thermal index values, or fail to display them altogether.

Recall initiated on 06/04/2008. Under the Siemens update program, all consignees will receive a visit from Siemens service personal to install the revised software version. Siemens staff will coordinate with foreign distributors to arrange for service abroad.

Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02, manufactured by Siemens Ultrasound

Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with the C8-5 transducer. This is a required display to support the alara principle when imaging cranial structure.

Field correction was initiated on 8/19/2008. Under Siemens update program US020/08/S & US021/08/S Siemens service personnel make a site visit, deliver a customer safety advisory notice to the customer and correct the problem by installing the revised Software versions. After the planned field correction is performed at the customer site the Service personnel log that information through Siemens internal web or reporting tools into the Siemens field update database.

Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and (Version 2.6); Serial Number(s): ALL;

If the time and date are not set correctly on both the user's meter and computer, there is the potential for incorrect times and dates to be assigned to the results in the Precision Link Software.