Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus

FDA Recall Z-0614-2018 · Posted None

Recalling FirmSiemens Medical Solutions USA, INC
Recall StatusTerminated
Product CodeOWB
Date Initiated2017-08-22
Date Terminated2018-08-21
Product Quantity207 worldwide (13 distributed in US)

Reason for Recall

The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen

Firm Action

Siemens sent an Urgent- Medical Device Correction letter dated August 22, 2017. Our service organization will contact you shortly to arrange a date to perform this corrective action (A system hardware update will be implemented and all affected DP Transceivers below revision 03 will be updated). Following the system hardware update, the cause is eliminated and a recurrence of the fault is prevented. For further questions, please call (610) 448-6461.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Distribution to the states of : AR, MO, NY, IN, AR, TX , NC, PA, MI, LA, WA, CA and AL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑