—#166917

Product

ARTIS Pheno Interventional 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: 164013 164011

Why it was recalled

Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).

Root cause (FDA determination)

Device Design

Action the firm took

Urgent Medical Device Correction notification letters dated 7/27/18 were distributed to customers. The letters informed the customers of the following planned actions: Our service organization will contact you shortly to arrange a date to perform this corrective action with Update Instruction AX001/18/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: US nationwide distribution.

Timeline

Recall initiated: 2018-07-29
Terminated: 2019-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166917. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.