Recall Z-1119-2015 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
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 proced
| Date | Feb 17, 2015 (initiated Jan 16, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| 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. |
| Quantity | 1 |
| Distribution | Nationwide Distribution to MI only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133580 | ARTIS ONE Siemens Medical Solutions USA, Inc., Apr 28, 2014 |