—#128483

Product

Artis zee and Artis zeego systems. x-ray, angiographic system

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K073290
Affected lot / code info: running software version VC21B 10094135, 10094137, 10094141, 10280959 with multiple serial numbers .

Why it was recalled

There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances, the release of radiation can become blocked unnecessarily.

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent an "Important Customer Safety Notice" dated August 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please forward this Safety information to other organizations that could be affected by this measure. If the device has been sold and therefore no longer in your possession, please forward this safety 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 Customer Safety Notice and comply with the corresponding measures until the update has been fully completed. For further questions please call (610) 219-6300.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2014-06-05
Posted by FDA: 2014-09-22
Terminated: 2015-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128483. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.