—#119729

Product

Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K090745
Affected lot / code info: Material number 10094137 -- serial numbers 147515, 147500, 147528, 147514, 147516, 147526; material number 10094141 -- serial numbers 154408, 154406, 154453, 154423, 154430, 154425, 154429; material number 10280959 -- serial numbers 160813, 160823, 160812, 160800, 160431, 160814, 160807, 160817, 160816; material number 10094139 -- serial number 157907.

Why it was recalled

During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail.

Root cause (FDA determination)

Device Design

Action the firm took

Siemens sent an Urgent Customer Information letter to their consignees. The letter identified the affected product, problem , update Instructions and actions to be taken. Siemens began to equip affected systems with a modified board assembly in January, 2013.

Recalling firm

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

Distribution

Distribution pattern: United States Nationwide Distribution - including the states of: CA, CO, FL, IA, IL, IN, MA, MD, MI, NC, NY, PA, TX, VA and WA and Puerto Rico.

Timeline

Recall initiated: 2013-01-31
Posted by FDA: 2013-07-17
Terminated: 2014-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119729. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.