—#137299

Product

Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K092519, K123375
Affected lot / code info: Model Number of device: 10496180, with serial numbers: 220755 101060 100509 220783 100662 220844 130208 102213 100862 101739 102125 102401 102402 130118 102024 102509 102477 102008 100751 101802 102089 101559 102407 130252 220915 220909 130267 101118 101313 101114 130180 100735 100495 102295 102532 220684 220725 102265 101638 102377 101432 102158 101864 130161 102374 102025 220511 102340 102197 101938 101647 100929 220206 100729 101201 101051 101220 101202 101206 101854 220448 220466 101565 100530 101612 102381 101561 220879 130174 102100 102418 100220 102120 220593 101137 101740 220577 102336 130125 101701 102335 101419 100748 101885 101578 101341 100460 102108 102175 100692 130122 101371 130378 100675 100700 101257 130229 220617 102021 100760 101338 102281 100718 101309 220888 101631 220920 100796 102405 220512 102435 100075 101444 100957 100039 102417 101043 101042 101066 220521 102127 101546 100705 220855 102420 102146 220742 102486 101797 101754 100633 102363 220743 130266 220454 100603 102074 101953 102173 102063 100892 100753 102163 220876 130140 130269 100734 101316 100845 101958 101200 101852 100484 220900 101038 101057 102355 100978 102014 130173 100917 101266 100389 101010 101650 100742 102360

Why it was recalled

measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print.

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent a Customer Advisory Notice, dated May 15, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to check the software version of their syngo.via system and consider whether the issue described in the advisory notice impact their clincal coutine and whether to arrange the installation of SY027/15/P (VA30A_HF07). Customers were advised to include the advisory notice in their operator's manual. Customers were also advised to notify anyone at their organization who should be aware of this information. For questions regarding this recall call 610-219-6300.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2015-05-15
Posted by FDA: 2015-06-03
Terminated: 2017-03-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137299. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.