David M. Smith
11-13-2008, 10:33 AM
Date Recall Initiated June 04, 2008
Date Posted September 19, 2008
Recall Number Z-2212-2008
Product 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.
Code Information HAE0563 HAE0564 HAE0565 HAE0566 ....... HAE0560 HAE0561 HAE0562 (For a complete list go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=71863)
Reason For Recall System may either display incorrect mechanical and thermal index values, or fail to display them altogether.
Action 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.
Quantity in Commerce 1230 units
Distribution Worldwide Distribution.
Date Posted September 19, 2008
Recall Number Z-2212-2008
Product 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.
Code Information HAE0563 HAE0564 HAE0565 HAE0566 ....... HAE0560 HAE0561 HAE0562 (For a complete list go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=71863)
Reason For Recall System may either display incorrect mechanical and thermal index values, or fail to display them altogether.
Action 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.
Quantity in Commerce 1230 units
Distribution Worldwide Distribution.