Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.
FDA Recall Z-1119-2015 · Posted 2015-02-17
Advertisement
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2015-01-16
Date Terminated2015-04-21
Product Quantity1
Reason for Recall
The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.
Firm Action
Siemens notified their customer via Customer Safety Advisory Letter AX049/14/S, dated January 16, 2015, and has initiated a fix with Update Instruction AX048/14/S which will be completed by a Siemens service technician. Customers with questions should contact the Customer Care Center at 1-800-888-7436.
For questions regarding this recall call 610-219-6300.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution to MI only
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement