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Terminated

syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673

FDA Recall Z-1216-2014 · Posted 2014-03-18

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2014-01-27
Date Terminated2015-03-16
Product Quantity50

Reason for Recall

Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis.

Firm Action

A recall notification letter, dated January 27, 2014, was sent to end Users. Customer Safety Advisory Letter SY016/14/S. Siemens is preparing a Service Patch modification of syngo Dynamics v9.5 which will be available in March 2014.

Root Cause

Software design

Distribution Pattern

Nationwide distribution to MN, AR, MA, TX, NJ, WV, GA, CA, PA, OH, MI, WI, TN, NY, KS, CT, NY, MO, IL, IN, OR, IA, and WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102150SYNGO DYNAMICS, VERSION 9.0Siemens Medical Solutions USA, Inc. · 2010-10-05K023772KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMAcuson Corp. · 2002-11-22

Official Source

View FDA Recall →

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

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