Recall Z-1706-2015 ยท BSZ Gas-Machine, Anesthesia
Maquet Cardiovascular Us Sales, Llc
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
| Date | Jun 8, 2015 (initiated Apr 2, 2015) |
| Status | Terminated |
| Reason | In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation. |
| Root cause | Under Investigation by firm |
| Action | The firm, Maquet Inc., sent an "Urgent Medical Device Field Action Field Correction for FLOW-i Anesthesia Systems" letter dated 4/2/2015 via FedEx. The letter describes the product, problem and actions to be taken. The customers were instructed to read the letter and inform staff, who may use the FLOW-i Anesthesia System of the patient cassette locking device issue. Customers are to obtain the serial number of their system; verify the serial number obtained against the serial number listed in the box in the Appendix. A Maquet Service Representative will be contacting you to arrange a conveni |
| Quantity | 1641 [80 units (US) 1561 units (OUS)] |
| Distribution | Class I Recall - Worldwide distribution -- US, including the states of AL, AZ, DC, FL, MI, MO, NJ, NY, OR, PA, TX, and WV; and, countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, Hungar |
| 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 |