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Terminated

Siemens syngo Imaging XS. Radiological image processing system.

FDA Recall Z-1064-2012 · Posted 2012-02-20

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2012-01-26
Date Terminated2012-09-29
Product Quantity128

Reason for Recall

In September 2011 firm issued two Customer Safety Advisory Notices for syngo Imaging XS. Firm became aware of an unintended behavior when using syngo Imaging XS, version VA70A and VA70B with Client/Server Installations. Loading additional images/series from the Patient Browser using the thumbnails may cause unintended deletion of images/series. In response, firm issued a Customer Safety Advisor

Firm Action

Siemens Medical issued an "UPDATE INSTRUCTIONS SY055/11/S/UPDATE PACKAGE VA70B_0211" to all affected customers. The package described the product, problem, and instructions for customers to follow.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution-including the states of CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082430SYNGO IMAGING XSSiemens AG Medical Solutions · 2008-11-14

Official Source

View FDA Recall →

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

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