—#116768

Product

Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration 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: Model number 10280959 -- serial numbers 160395, 160484, 190348, 160502, 160351, 160463, 160823, 160406, 160347, 160506, 160142, 160801, 160486, 160431, 160100, 160814, 160391, 160008, 160411, 160438, 160450, 160149, 160830, 160483, 160813, 160460, 160485, 160443, 160122, 160401, 160494, 160507, 160007, 160001, 160825, 160508, 160482, 160505, 160322, 160323, 160382, 160421, 160129, 160357, 160498, 160413, 160414, 160373, 160509, 160817, 160101 and 160469.

Why it was recalled

In the course of the firm's product monitoring activities, a potential risk for patient or operators was determined during the operation of an Artis zeego system with software revision VC14, VC20 and VC21 in conjunction with a specific technical configuration which cannot be completely executed.

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent an Urgent Customer Information letter dated November 8, 2012 to affected consignees. The letter notified consignees of the issue and informed them the update AX039/12/S would be started and affected systems would be checked and corrected if required. Customers were instructed that they would be contacted to arrange a date for checking their system. For questions regarding this recall call 610-219-6300.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution including AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, LA, MD, MI, MO, NC, NH, OR, PA, SD, TN, TX, WA and WI and Puerto Rico.

Timeline

Recall initiated: 2012-11-26
Posted by FDA: 2013-03-25
Terminated: 2013-12-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116768. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.