—#136101

Product

SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133424
Affected lot / code info: SOMATOM Emotion 6 (2007) - 10165888 with serial numbers: 29338 27232 27230 27231

Why it was recalled

Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent an Customer Safety Advisory Notice dated April 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A remote software update is scheduled for release that will resolve the issue. For further questions, please 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 including Puerto Rico.

Timeline

Recall initiated: 2015-04-20
Posted by FDA: 2015-05-22
Terminated: 2016-09-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136101. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.