—#106994

Product

AXIOM Artis and AXIOM Artis zee modular angiographic systems Product Usage: Angiographic x-ray systems

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K052202
Affected lot / code info: Model numbers 5904433, 5904441, 5904649, 5904656, 5904466, 7007755, 7728350, 7412807, 7727717, 7728392, 7413078, 7555373, 7555365, 7555357, 7008605, 5917054, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, and 10280959.

Why it was recalled

There is a potential misalignment in the connection of the remote foot switch and the stationary unit. This potential malfunction may occur if either the wireless foot switch or the stationary unit is equipped with improper firmware installed in the bluetooth interface performing the communication between foot switch and system. This is not a general issue but sporadic as a vendor unsystematical

Root cause (FDA determination)

Software change control

Action the firm took

Siemens sent an Urgent Field Safety Notice letter on January 16, 2016, to all affected customers The letter identified the product, problem, potential risk, and actions to be taken. Customers were instructed to immediately pass this information to all those who need to be aware and instruct personnel accordingly. Siemens ask that if the device/equipment is no longer in the customers possession to forward this safety notice to the new owner of the device/equipment.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution (USA) including the states of: CA, CT, FL, GA, HI, IL, IN, KY, ME, MD, MI, MS, MO, NH, NJ, NY, NC, OH, OR, TN, TX, UT, VA, WI and Puerto Rico.

Timeline

Recall initiated: 2012-01-16
Posted by FDA: 2012-01-27
Terminated: 2014-01-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106994. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.