Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not
FDA device recall Z-1119-2015 · posted 2015-02-17 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 1
- Distribution
- Nationwide Distribution to MI only
- Date initiated
- 2015-01-16
- Date posted
- 2015-02-17
- Date terminated
- 2015-04-21
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS ONE (K133580) | Siemens Medical Solutions USA, Inc. | 2014-04-28 |