Recall Z-1925-2012— Maquet Cardiovascular Us Sales, Llc

Name: FDA recall Z-1925-2012
Creator: U.S. Food and Drug Administration
Published: 2012-02-20

Class I · Terminated

Class I FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2012-02-20, terminated 2015-09-09. It names one FDA 510(k) clearance: K112114. Product: FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.. Reason: A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the "on" or "off" position but remains in the "in-between position..

Recalling firm: Maquet Cardiovascular Us Sales, Llc
Classification: Class I
Status: Terminated
Initiated: 2012-02-20
Terminated: 2015-09-09
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K112114 — MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40Maquet Critical Care AB·cleared 2012-01-13

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 The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.

Reason for recall

A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the "on" or "off" position but remains in the "in-between position.

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