Recall Z-0804-2016— Maquet Cardiovascular Us Sales, Llc

Name: FDA recall Z-0804-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-10

Class I · Terminated

Class I FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2015-12-10, terminated 2016-07-06. It names one FDA 510(k) clearance: K133958. Product: 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 environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.. 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..

Recalling firm: Maquet Cardiovascular Us Sales, Llc
Classification: Class I
Status: Terminated
Initiated: 2015-12-10
Terminated: 2016-07-06
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K133958 — FLOW-I ANESTHESIA SYSTEM C20, C30 & C40Maquet Critical Care AB·cleared 2014-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.