—#99559

Product

syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and manipulation of digital medical images, including quantification and report generation. It is not intended to be used for the reading of mammography images.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K102150
Affected lot / code info: 10091602, 10091604

Why it was recalled

If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to reports failing to save and/or marking the study as read might leave the study in an unread state or might mark the study as read but leave the report with a "Preliminary" watermark displayed.

Root cause (FDA determination)

Software design

Action the firm took

The firm, SIEMENS, sent a "Customer Safety Advisory Notice" letter dated March 24, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to place graphs in sections and not tables in the report; avoid deleting graphs from the reports in run-time and include this safety advisory notice in their operator's manual where it should remain until the service patch is applied. SIEMENS will be issuing a service patch to fix the defect. The letter states the patch will be available in the next few weeks. If you have any questions, call +1 (734) 205-2400.

Recalling firm

Firm: Siemens Medical Solutions, USA, Inc
Address: 400 Morgan Rd, Ann Arbor, Michigan 48108

Distribution

Distribution pattern: Nationwide distribution: USA including states of: CA, CT, FL, ID, MD, MI, MN, NJ, NY and PA.

Timeline

Recall initiated: 2011-03-24
Posted by FDA: 2011-05-25
Terminated: 2012-07-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99559. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.