—#141582

Product

Syngo Imaging VB36D_HF02. Radiological image processing system.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K071114, K081734
Affected lot / code info: model# 10014063 and 10014064

Why it was recalled

To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D.

Root cause (FDA determination)

Software change control

Action the firm took

Siemens sent an Customer Information Letter dated October 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions, please call: (610) 219-6300.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Distribution to the states of : NC, NE and OH.

Timeline

Recall initiated: 2015-10-28
Posted by FDA: 2015-11-20
Terminated: 2016-10-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141582. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.