Recall Z-0804-2016 ยท BSZ Gas-Machine, Anesthesia
Maquet Cardiovascular Us Sales, Llc
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environm
| Date | Feb 22, 2016 (initiated Dec 10, 2015) |
| Status | Terminated |
| Reason | Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement PCBs are now available to correct the issues. Only the Model C20 is affected in the US. |
| Root cause | Nonconforming Material/Component |
| Action | Maquet sent "Urgent Medical Device Field Action Field Correction For Flow-i Anesthesia Systems" letters/Field Correction Response forms dated 12/10/2015 via UPS to affected customers. The notification informed customers of the issue, asked them to distribute the notification to appropriate staff; verify the serial number(s) and informed them they could continue to use the system if they were not experiencing electrical issues. Customers were informed that a Maquet service representative would be contacting them to arrange a time to replace their affected units. Customers were asked to com |
| Quantity | 7 units within US |
| Distribution | US Nationwide in the states of CA, NY, and OR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133958 | FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 Maquet Critical Care AB, Mar 20, 2014 |