Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading of mammography images.
FDA Recall Z-1183-2016 · Posted None
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-01-25
Date Terminated2018-06-29
Product Quantity228 units
Reason for Recall
Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics.
Firm Action
The firm, Siemens Healthcare, sent a "Customer Advisory Notice" dated 1/19/2016 to customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions provided on what steps the user can take to avoid the issue and to forward the notice to the new owner, if you sold this device/equipment and its no longer in your possession. Siemens is preparing a modification of syngo Dynamics that will resolve this potential malfunction.
If you have any question, contact Regulatory Technician Specialist at 610-448-6478 or email: [email protected].
Root Cause
Software design
Distribution Pattern
US Nationwide Distribution including states of: MN, NC, NE, FL, TX, CA, AR, MI, MA, IL, DE, VA, SC, OH, CO, WI, MO, NY, CT, UT, PA, WA, NJ, GA, IN, MD, TN, LA, OR, AZ, ND, KS, AL, NM.
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.