—#143694

Product

software for Syngo Dynamics 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. Syngo Dynamics is not intended to be used for reading of mammography images.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K023772, K102150
Affected lot / code info: For model #10091673

Why it was recalled

Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.

Root cause (FDA determination)

Software design

Action the firm took

The firm, Siemens Healthcare, sent a "Customer Advisory Notice" dated 1/19/2019 to its customers.The notice described the product, problem and actions to be taken. The customers were instructed to create a new department if immediate resolution is necessary, use workplace for reporting and hand over the customer letter before or during installation of field modification(PSL) distributed with Update Instruction SY013/16P. A software update to resolve reported issues is being released via an Update Instruction SY013/16/P. If you have any questions, contact Regulatory Technical Specialist at 610-448-6478 or email: anastasia.sokolova@siemens.com.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide Distribution including states of: AL AR AZ CA CO CT DE FL GA IL IN KS LA MA MD MI MN MO NC ND NE NJ NM NY OH OR PA SC TN TX UT VA WA and WI.

Timeline

Recall initiated: 2016-01-29
Posted by FDA: 2016-02-19
Terminated: 2017-02-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143694. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.