—#165393

Product

ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K163286
Affected lot / code info: 164033, 164071, 164034, 164095, 164057, 164054, 164055, 164080, 164072, 164088, 164048, 164094, 164068, 164019, 164013, 164073, 164025, 164026, 164027, 164060, 164083, 164021, 164066, 164075, 164074, 164084, 164086, 164098, 164028, 164053, 164063, 164064, 164024, 164049, 164018, 164022, 164061, 164100, 164097, 164011

Why it was recalled

During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).

Root cause (FDA determination)

Device Design

Action the firm took

An Urgent Medical Device Correction notification was distributed to customers on 5/30/18. The notification provided the following information to customers: Siemens will correct the error by inspecting all affected ARTIS Pheno systems. As an immediate measure to prevent movement stops during a C-arm rotation followed by a C-arm drop, the maximum rotation speeds will be reduced. This correction limits the maximum manual LAO/RAO rotation from 25/sec to 20/sec and Cran/Caud rotation from 20/sec to 10/sec. All other system parameters as well as 3D acquisition and Perivision/Peristepping remain unaffected. You may continue to use the ARTIS Pheno system while awaiting implementation of the corrective action. Our service organization will contact you shortly to arrange a date to perform this corrective action with Update Instruction AX004/18/S. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented. Additionally, Siemens is developing a solution to restore the system back to the original settings. This solution will be distributed to all affected customers upon completion.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: The devices were distributed to the following US states: AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, ME, NJ, NY, OH, TN, TX, UT, and VA.

Timeline

Recall initiated: 2018-05-30
Terminated: 2020-02-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165393. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.