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Terminated

Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system.

FDA Recall Z-0652-2007 · Posted 2007-03-28

Recalling FirmSiemens Medical Solutions, USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2007-01-31
Date Terminated2008-04-30
Product Quantity71

Reason for Recall

The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a software defect.

Firm Action

Distributors were issued a recall letter dated 1/29/07 and asked to notify their customers by issuing their subaccounts a similar letter. When available, new software will be provided.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053133SYNGO DYNAMICS, VERSION 5.0Siemens Medical Solutions USA, Inc. · 2005-12-05

Official Source

View FDA Recall →

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

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