KinetDx 4.0 Ultrasound Image Management System.
FDA Recall Z-1235-06 · Posted 2006-07-13
Recalling FirmSiemens Medical Solutions, USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2006-04-06
Date Terminated2007-05-01
Product Quantity244
Reason for Recall
The cardiologist's report comments may not be retained by the system due to a software bug.
Firm Action
In April 2006, Siemens' field force was issued instructions to visit each customer location and to complete the software upgrades within six months.
Root Cause
Other
Distribution Pattern
Nationwide.
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.