—#119960

Product

Siemens AXIOM Artis zeego 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 number 10280959

Why it was recalled

Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system.

Root cause (FDA determination)

Software design

Action the firm took

The firm, Siemens, sent an "Important safety notice" by letter on May 13, 2013 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to immediately notify the service department to clarify what further measures need to be taken, if after carrying out the regular brake test, the system can only be moved at a reduced speed. If this device has been sold and is therefore no longer in your possession, send this safety notice to the new owner and provide the new owner to Siemens. Update instruction AX012/13/S was issued, and a software update will be released as AX006/13/S and AX007/13/S which will modify the system software so that it will not be possible for information to be overlaid. If you have any questions call +49 (9191) 18 0.

Recalling firm

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

Distribution

Distribution pattern: Nationwide distribution: AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MD, MN, MO,MS, NC, NE, NH, NJ, NY, OH, PA, PR, SD, TN, TX, UT, VA, WA, and WI.

Timeline

Recall initiated: 2013-05-13
Posted by FDA: 2013-08-09
Terminated: 2014-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119960. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.