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Terminated

Leonardo Workstations with software versions prior to 2022A

FDA Recall Z-1089-03 · Posted 2003-08-07

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2003-02-28
Date Terminated2004-12-23
Product Quantity1374 units

Reason for Recall

software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.

Firm Action

The recalling firm issued three separate customer advisory letters dated 2/28/03, 03/01/03, and 4/14/03 to their customers explaining the problem and the preventive measure to avoid loss of information.

Root Cause

Other

Distribution Pattern

The product was shipped to distributors, medical facilities and Siemens training facilities nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010938SYNGO MULTIMODALITY WORKSTATIONSiemens Medical Solutions USA, Inc. · 2001-06-26

Official Source

View FDA Recall →

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

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