Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1423-2010

Syngo Imaging XS model number 10496279 The

Siemens Medical Solutions USA, Inc. / initiated 2010-02-16 / Terminated / root cause: software

Siemens Medical Solutions USA, Inc began a recall of Syngo Imaging XS model number 10496279 The intended use: image processing radiological on . The reason FDA records is "images can be overwritten". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1423-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
Syngo Imaging XS model number 10496279 The intended use: image processing radiological
Product code
LLZ System, Image Processing, Radiological
Reason for recall
images can be overwritten
Root cause tag
software
FDA root cause
Software design
Action
A "Customer (Safety) Advisory notice" dated February 16, 2010, was sent all affected customers via Update Instructions IM019/10/S. This notice describes the product, problem and the action to be taken by the customers. The customers should immediately instruct their employees of the advisor notice and maintain awareness. If the customer sold the device/equipment and is no longer in possession of it, they should forward the notice and inform Siemens of the new owner. A software update to correct this issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instructions IM020/10/S. If you have any further questions regarding this issue, do not hesitate to contact your local SIEMENS Uptime Service Center ([email protected]).
Quantity in commerce
6 units
Distribution
Nationwide distribution: CA, NC, NY, PA, and TX
Product codes and lots
Model number 10496279. Serial numbers: 1165, 1213, 1361, 1373, 1395, and 1424.