—#120170

Product

Artis zee systems x-ray, angiographic system

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K090745
Affected lot / code info: model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot

Why it was recalled

The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.

Root cause (FDA determination)

Device Design

Action the firm took

Siemens sent an letter to all affected customers in January 2013, notifying them of the potential issue and urging customers to make appointments with Siemens to have software update AX 027/12/S realized in order to resolve the problem. The software update was made available from January 22, 2013, on. Customers were also asked to pass along this information if the device was no longer in their possession. The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 17 unit(s) will consist of the following: 1. The firm sent out a customer notification letter in January 2013 notifying them of the issue and highlighting the approved procedures of the Corrective Action Plan. 2. Siemens directed in the customer notification letter, for the end-user to make an appointment with the Customer Service organization to have safety update AX 027/12/S realized. 3. As stated in the safety update AX 027/12/S and in the e-mail response the update to correct this issue will be provided to the customer at no expense. 4. Siemens indicated in the customer notification letter that the AX 027/12/S update will be made available from January 22, 2013 and on. 5. The AX 027/12/S update provides general information, work instructions and a completion certificate on how to correct the dislocated scatter radiation filter inside the collimator. You may proceed with implementation of the CAP (subject to the conditions noted above). 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: US Distribution including the states of AZ, KY, PA, IA WV, FL, MO, OK, CA, AR, MT, NY, KS, and CT.

Timeline

Recall initiated: 2013-01-21
Posted by FDA: 2013-11-14
Terminated: 2014-10-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120170. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.