Recall Z-0927-2012 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Siemens Medical Solutions USA, Inc
AXIOM Artis and AXIOM Artis zee modular angiographic systems Product Usage: Angiographic x-ray systems
| Date | Jan 27, 2012 (initiated Jan 16, 2012) |
| Status | Terminated |
| Reason | 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 | Software change control |
| 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. |
| Quantity | 45 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052202 | AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM Siemens Medical Solutions USA, Inc., Mar 7, 2006 |