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Terminated

CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833. Picture Archiving and Communications System.

FDA Recall Z-0647-2009 · Posted 2009-01-08

Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-11-13
Date Terminated2013-03-19
Product Quantity374 units

Reason for Recall

Indicated orientation does not match actual orientation of the patient.

Firm Action

The recalling firm issued a Customer Safety Advisory dated 10/8/08 to affected customers via Update Instructions CT052/08/S. The letter informs customers of the potential issue and provides instructions to avoid its occurrence. Customers should consider "no saving of calculated Dual Energy data sets from non-supine and mirror-option scans via "Save Sets CT"-button." The firm also highly recommends for customers "to check the correct display of "left", "anterior" and "posterior"markings, e.g. by checking the position of the spine with respect to the posterior marking in the image." The error should be fixed within certain upgrade and installation activities on the affected software.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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