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Terminated

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.

FDA Recall Z-2212-2008 · Posted 2008-09-19

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2008-06-04
Date Terminated2010-12-20
Product Quantity1230 units

Reason for Recall

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

Firm 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.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050240MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEMSiemens Medical Solutions USA, Inc. · 2005-02-15K042770MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEMSiemens Medical Solutions USA, Inc. · 2004-10-20K042044ACUSON CV70 CARDIOVASCULAR SYSTEMSiemens Medical Solutions USA, Inc. · 2004-08-13K032111ACUSON CV70 CARDIOVASCULAR SYSTEMSiemens Medical Solutions USA, Inc. · 2003-07-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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