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Terminated

Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system

FDA Recall Z-1751-2008 · Posted 2008-09-29

Recalling FirmSiemens Medical Solutions, USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-02-08
Date Terminated2009-11-18
Product Quantity18

Reason for Recall

Incorrect data: A software bug may result in a transfer of patient demographic data to a different patient's file.

Firm Action

Siemens issued a customer safety advisory to users on 2/8/08 advising them of the problem and instructing them to complete and verify that the report is locked before opening and reporting on a second patient, and that a software patch will be available Spring 2008.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution: Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Missouri, Montana, North Carolina, Texas and Utah.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070322SYNGO DYNAMICS, VERSION 6.0Siemens Medical Solutions USA, Inc. · 2007-02-27

Official Source

View FDA Recall →

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

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