—#144719

Product

AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K073290
Affected lot / code info: Serial Numbers: Artis Q Ceiling 109033, 109135, 109141, 109123, 109080, 109074, 109119, 109016, 109118, 109155, 109067, 109066, 109068, 109134, 109133, 109084, 109011, 109096, 109159, 109130, 109143, 109102, 109015, 109144, 109009, 109057, 109108, 109103, 109038, 109040, 109034, 109129, 109137, 109029, 109136, 109064, 109132, 109058, 109145, 109050, 109076, 109007, 109072, 109075, 109071, 109091, 109090, 109041, 109039, 109060, 109146, 109088, 109092, 109032, 109021, 109048, 109020, 109036, 109043, 109161, 109101, 109105, 109104, 109107, 109047, 109031, 109028, 109027, 109120, 109010, 109093, 109157, 109156, 109069, 109158, 109044

Why it was recalled

Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. This leak can occur sporadically in affected systems.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

Siemens sent an Important Customer Safety Notice to customers on February 18, 2016 informing them that their service organization will contact them to arrange a date to perform the corrective action (replacement of affected plastic couplings with metal couplings to prevent fluid leaks). Customers were advised to contact Siemens service organization for an earlier appointment at 1-800-888-7436.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including Puerto Rico.

Timeline

Recall initiated: 2016-02-18
Posted by FDA: 2016-03-31
Terminated: 2017-08-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144719. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.