Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887,

FDA device recall Z-1107-2004 · posted 2008-02-15 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc.

Reason for recall

Software error: Error affects all Aspen customer systems using the PAL video standard configuration and have a Perspective PC installed. This can lead to a measurement error under this specific condition: On secondary capture images/clips stored from within any Perspective advanced display option (specifically: 3D Surface Rendering, 3D MultiPlanar Reconstruction, Color Doppler 3D MultiPlanar Reco

Action taken

Siemens issued an Urgent Medical Device Notification to consignees 9/18/07, under Siemens update program US014/07/S. (Distribution on this product had ceased on 6/29/2005.) The firm has instructed the user to not take measurements or use measurements on these secondary captures under the conditions described in the notice, to place a copy of the instructions for use in the file, and to notify all users of the issue with the software. The Siemens Service organization has coordinated the implementation of the field correction with the distributors for all countries. Non-responding consignees will be visited or called by telephone for follow up.

Root cause

Software design

Status

Terminated

Product code

IYN

Quantity affected

280 units

Distribution

Worldwide Distribution --- including USA and countries of Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain (UK), Greece, Hong Kong,

Date initiated

2007-09-18

Date posted

2008-02-15

Date terminated

2011-04-21

Location

Mountain View, CA

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