—#120167

Product

Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K021021
Affected lot / code info: Multiple Model numbers: 10281163, 10281013, 10280959, 10272410, 10094200, 10094142, 10094141, 10094139, 10094137, 10094135, 10093961, 10093902, 8890415, 8890407, 8627718, 8395431, 8395415, 8395399, 8395381, 7728392, 7555373, 755365, 7555357, 7412807, 7151066, 7008605, 5904441, 5904433, 5895003, 475525, 475517, 475509.

Why it was recalled

The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Siemens sent Update Instructions dated December 2012, to all affected customers. This update was initiated on behalf of the US service organization to re-check all systems installed by MEC Group. A call center representative or designated engineer called each site on April 26, 2013, and described the work being done, amount of time needed and number of engineers that would be on site. At that time the call center or engineer scheduled the update with the customer. For further questions please call (610) 219-6300.

Recalling firm

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

Distribution

Distribution pattern: US Distribution including the states of PA, NJ, DC, VA, MD and DE.

Timeline

Recall initiated: 2013-04-26
Posted by FDA: 2013-08-28
Terminated: 2014-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120167. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.