—#111087

Product

syngo Dynamics Version 9.5

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K102150
Affected lot / code info: 10091862 and 10091863

Why it was recalled

If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study.

Root cause (FDA determination)

Software design

Action the firm took

On 07/13/2012, Siemens issued a "Customer Safety Advisory Notice" to affected consignees according to Update Instruction SY062/121S. The notice informs the customers of the potential issue with the identified affected product and provides details regarding the resolution. A software update to relieve the symptom of the issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instruction SY063/121S. A software update to correct this issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instruction SY064/121S.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC.

Timeline

Recall initiated: 2012-07-13
Posted by FDA: 2012-08-17
Terminated: 2013-07-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111087. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.