The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

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:

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