ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA, Inc., Mountain View, CA
FDA Recall Z-0661-2008 · Posted 2008-04-24
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Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2007-09-25
Date Terminated2010-12-20
Product Quantity280
Reason for Recall
Measurement Error affecting all Sequoia systems using the PAL video standard configuration and have a perspective PC installed: 1) The Sequoia" system is operating at a software revision below 8.0. 2) The Sequoia" system is configured to PAL video mode (normal for systems running at 240V 50 Hz.). 3) While using any of the Perspective" advanced display options listed above, an image or clip is t
Firm Action
Consignees were notified via a Urgent Medical Device Notification letter/customer letter sent out on 9/25/2007 under Siemens update program US013/07/S. The Siemens Service organization coordinates the implementation of the field correction with the distributors for all countries. Consignees who do not respond to the recall communication will be visit ed and/or telephoned for follow up.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution including the countries of: Australia, Austria, Belgium, Brazil, Brunei, China, Denmark, Finland, France, Germany, Great Britain (UK), Greece, Hungary, India, Iran, Ireland, Italy, Latvia, Netherlands, New Zealand, Romania, Russian Federation, Singapore, Spain, Switzerland, Thailand. U.S customers were not affected.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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