Siemens KinetDx 4.2 Workplace, Siemens Medical Solutions, Ann Arbor, MI; 10090235. Indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information.
FDA Recall Z-0543-2009 · Posted 2009-01-02
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Recalling FirmSiemens Medical Solutions, USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-07-23
Date Terminated2010-10-18
Product Quantity306 of all products.
Reason for Recall
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Firm Action
Consignees were notified of the problem via a Customer Safety Advisory Notice dated 7/23/08, which provided guidance on how to minimize the risk of the problem occurring, and told customers that a service patch will be installed when it becomes available.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution.
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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