Maquet Cardiovascular Us Sales, Llc: Medical Device Recall in 2012 - (Recall #: Z-1925-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: February 20, 2012

Date Posted: July 18, 2012

Recall Number: Z-1925-2012

Event ID: 62118

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.

Status: Terminated

Product Quantity: 284 units

Code Information:

Model Number :6677300 Serial Number : 1170

Distribution Pattern:

Worldwide distribution: USA (nationwide) state of GA only and countries of: Argentina, Australia, Austria, Belgium, China, Czech Republic, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, Spain, Sweden incl Maquet Critical Care, Switzerland, Thailand, United Arab Emirates, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated