AXIOM Artis and AXIOM Artis zee modular angiographic systems Product Usage: Angiographic x-ray systems
FDA Recall Z-0927-2012 · Posted 2012-01-27
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2012-01-16
Date Terminated2014-01-31
Product Quantity45
Reason for Recall
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
Firm Action
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.
Root Cause
Software change control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.