Recall Z-2379-2018 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Smiths Medical ASD Inc.
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.) Product Usage: The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital o
| Date | Nov 29, 2017 |
| Status | Terminated |
| Reason | Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print feature). |
| Root cause | Software design |
| Action | Smiths Medical sent an Urgent Medical Device Letters dated 11/29/2017 via FedEx tracked mailing. The letter identified the affected product, problem and actions to be taken. For questions call Smith Medical Customer Service at 1-800-258-5361. |
| Quantity | 10 devices |
| Distribution | Worldwide Distribution - US Nationwide in the states of CO and MT. Foreign distribution was to Armenia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030407 | ADVISOR, MODEL 9200 Bci, Inc., Aug 19, 2003 |