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Terminated

Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.

FDA Recall Z-1613-2014 · Posted 2014-05-13

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2014-04-03
Date Terminated2014-12-15
Product Quantity50

Reason for Recall

Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.

Firm Action

Siemens sent a Recall Notification letter dated March 26, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Siemens is preparing a Service Patch modification that would be performed to resolve the software issue.

Root Cause

Software design

Distribution Pattern

US Nationwide Distribution in the states of AR, CA, CT, GA, IA, IL, KS, MA, MI, MN, NJ, NM, NY, OH, OR, PA, TX, TN, TX, WA, WI, and WV.

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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