—#91460

Product

Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K082430
Affected lot / code info: Material number 10014063. Serial numbers 1043, 1114, and 1198. Version Lines VB20, VB30, & VB35.

Why it was recalled

Siemens has become aware of a potential malfunction and hazard to patients when using Syngo Imaging version lines VB20, VB30, VB35A in combination with a RIS that is violating DICOM Standard by creating non-unique study instance UIDs.

Root cause (FDA determination)

Device Design

Action the firm took

The recalling firm sent a Customer Safety Advisory Notice, dated 04-06-2010, to customers explaining when the malfunction occurs and the potential risks, steps to avoid potential risk of the issue by ensuring that the RIS works according to DICOM Standard and does not create double study instance UIDs. Siemens Service Reps will contact the consignees in a timely manner to check if there are symptoms for the reported issues. The issue will be resolved with a Software-Update for each affected version, except for version VB20. All customers on VB20 will be upgraded.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide Distribution -- Including CT, NM, & WI.

Timeline

Recall initiated: 2010-04-06
Posted by FDA: 2010-06-24
Terminated: 2012-07-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91460. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.