—#38458

Product

Axiom Artis X-Ray System using software version VB11D or VB20B

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K010721
Affected lot / code info: model numbers 5904433, 5904441, 5904466, 7007755, 7008605, 7412807, 7413078, 7555365, 7555373, 7727717, and 7728350

Why it was recalled

Live display in exam room may sporadically stop working although the display in the control room remains fully operational

Root cause (FDA determination)

Other

Action the firm took

The manufacturer provided a Customer Safety Advisory letter dated 3/24/05. The letter describes the problem and the interim work around. This letter was forward to the recalling firm''s direct accounts.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: The product was shipped to hospitals in AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA,WA,WI, and WV.

Timeline

Recall initiated: 2005-04-11
Posted by FDA: 2005-05-03
Terminated: 2006-08-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38458. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.