Recalls / —

—#89906

Product

Syngo Imaging XS model number 10496279 The intended use: image processing radiological

FDA product code

LLZ — System, Image Processing, Radiological

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K082430

Affected lot / code info

Model number 10496279. Serial numbers: 1165, 1213, 1361, 1373, 1395, and 1424.

Why it was recalled

images can be overwritten

Root cause (FDA determination)

Software design

Action the firm took

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 (michael.mib.braun@siemens.com).

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

Nationwide distribution: CA, NC, NY, PA, and TX

Timeline

Recall initiated

2010-02-16

Posted by FDA

2010-04-20

Terminated

2012-07-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #89906. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.