Recall Z-2212-2008 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
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.
| Date | Sep 19, 2008 (initiated Jun 4, 2008) |
| Status | Terminated |
| Reason | System may either display incorrect mechanical and thermal index values, or fail to display them altogether. |
| Root cause | Software design |
| 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 | 1230 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032111 | ACUSON CV70 CARDIOVASCULAR SYSTEM Siemens Medical Solutions USA, Inc., Jul 18, 2003 |
| K042044 | ACUSON CV70 CARDIOVASCULAR SYSTEM Siemens Medical Solutions USA, Inc., Aug 13, 2004 |
| K042770 | MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM Siemens Medical Solutions USA, Inc., Oct 20, 2004 |
| K050240 | MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM Siemens Medical Solutions USA, Inc., Feb 15, 2005 |