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Terminated

Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.

FDA Recall Z-1892-2010 · Posted 2010-06-24

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2010-04-06
Date Terminated2012-07-05
Product Quantity3 units

Reason for Recall

Siemens has become aware of a potential malfunction and hazard to patients when using Syngo Imaging version lines VB20, VB30, VB35A in combination with a RIS that is violating DICOM Standard by creating non-unique study instance UIDs.

Firm Action

The recalling firm sent a Customer Safety Advisory Notice, dated 04-06-2010, to customers explaining when the malfunction occurs and the potential risks, steps to avoid potential risk of the issue by ensuring that the RIS works according to DICOM Standard and does not create double study instance UIDs. Siemens Service Reps will contact the consignees in a timely manner to check if there are symptoms for the reported issues. The issue will be resolved with a Software-Update for each affected version, except for version VB20. All customers on VB20 will be upgraded.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution -- Including CT, NM, & 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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