The Recall Desk
LowFDA (Devices)·Z-1925-2012·Announced 2012-07-18

Maquet FLOW-i Anesthesia System Recalled for Technical Alarm Issue

Maquet is recalling 284 FLOW-i Anesthesia Systems because a technical alarm may be generated if the MAN/AUTO switch is not fully engaged.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classification is FDA Class I, which is defined as unlikely to cause adverse health consequences. The issue is a technical alarm generation rather than a direct physical hazard or injury.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling 284 units of the FLOW-i Anesthesia System. The system is intended for administering anesthesia and controlling ventilation for patients with no ability to breathe or limited ability to breathe.

The recall is due to a technical issue where an alarm may be generated when using the MAN/AUTO switch to change ventilation modes. This occurs if the switch is not fully engaged in the "on" or "off" position but remains in the "in-between" position.

The affected units were distributed worldwide, including the United States (nationwide, specifically the state of Georgia) and numerous international countries. The specific model number is 6677300 and the serial number is 1170. Users should contact the recalling firm for instructions on how to address this issue.

The recalled product

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.
Manufacturer
Maquet Cardiovascular Us Sales, Llc
Category
Medical Device — Anesthesia System
Hazard
Affected units
284

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model Number :6677300 Serial Number : 1170

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Maquet Cardiovascular Us Sales, Llc

See all →