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Terminated

Syngo Imaging with versions VB20B, VB20D, VB20F, VB20G, VB25B, VB30A, VB30A_SP1, and VB30A_SP2.

FDA Recall Z-0102-2009 · Posted 2008-10-15

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-08-22
Date Terminated2008-11-19
Product Quantity59 units

Reason for Recall

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Firm Action

The recalling firm issued Customer Safety Advisory Notice dated 8/22/08 to inform the consignees of the potential issue and provide instruction to avoid its occurrence. To avoid potential risk of this issue, users are asked to check whether the extended HL7 messages as stated in the letter are mandatory for their RIS-PACS workflow, and disable these messages if they are not. Siemens is preparing a modification under the UI IM086/08/S for the affected versions of syngo Imaging that will resolve the potential malfunction. The field modification will be immediately distributed and installed by the firm's Service as soon as it is available.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution --- including states of AL, AZ, CA, CO, CT, FL, IA, KS, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, TN, TX, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071114SYNGO IMAGING (VERSION V30)Siemens AG Medical Solutions · 2007-05-22K052461SYNGO IMAGING VERSION V20ASiemens AG Medical Solutions · 2005-09-22

Official Source

View FDA Recall →

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

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