—#128317

Product

AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K010721, K073290
Affected lot / code info: material number 3771750, model numbers: 5904441, 5904466, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, and 10280959

Why it was recalled

There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in uncontrolled release of an x-ray image.

Root cause (FDA determination)

Device Design

Action the firm took

Siemens sent an Important Safety Information letter dated June 5, 2014, to affected customers. The letter described the affected product, problem, and actions to be taken. Customers were instructed to observe this safety notice and comply with the corresponding measures until the update has been fully completed.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution.

Timeline

Recall initiated: 2014-06-05
Posted by FDA: 2014-09-24
Terminated: 2015-04-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128317. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.