Recall Z-3190-2018 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
| Date | Jul 29, 2018 |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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 se |
| Quantity | 429 total |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163286 | ARTIS pheno Siemens Medical Solution USA, Inc., Mar 9, 2017 |