Recall Z-2083-2015 ยท BSZ Gas-Machine, Anesthesia
Maquet Cardiovascular Us Sales, Llc
The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.The system is intended for use in a wide range of population: from neonatal to a
| Date | Jul 15, 2015 (initiated Mar 2, 2015) |
| Status | Terminated |
| Reason | Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the suction unit on/off switch leading to a decrease or loss of suctioning capability of the modules. |
| Root cause | Under Investigation by firm |
| Action | Maquet sent an Urgent Medical Device Field Action Removal and Replacement Form/Device Removal Response Form dated March 2, 2015 to their affected customers via FedEx. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed read through the letter and inform all members of their staff who may use the affected device. Fill out the attached Device Removal Response Form with requested information, sign and date and fax/email the Response Form using the fax/email information provided. Customers with questions were instructed to conta |
| Quantity | 104 units |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, India, Israel, Japan, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, Sou |
| 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 |