The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0804-2016·Announced 2016-03-02

Maquet Flow-i Anesthesia System Recalled for Electrical Control Issues

Maquet is recalling seven Flow-i Anesthesia Systems in the US due to electrical issues in control and monitoring sub-systems that can cause restarts or system disabling.

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: "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…"

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling seven units of the Flow-i Anesthesia System in the United States. The recall affects only Model C20 units, which are used to administer inhalation anesthesia and control ventilation for patients who cannot breathe on their own or have limited breathing ability. The systems are intended for use in hospital environments by trained healthcare professionals.

The recall is due to electrical issues in the control, monitoring, or panel sub-systems caused by printed circuit boards (PCBs). These issues have manifested as multiple restarts of the sub-systems and, in a few instances, the disabling of the system. Replacement PCBs are available to correct the issues.

The affected units were distributed nationwide in California, New York, and Oregon. Healthcare professionals should stop using the affected devices and contact Maquet for replacement parts.

The recalled product

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.…
Manufacturer
Maquet Cardiovascular Us Sales, Llc
Category
Medical Device — Anesthesia System
Hazard
Affected units
7

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 (8)

  • Model numbers: C20
  • C30 and C40 (Only Model # C20 for US) Part numbers: 66 77 200 (US Only)
  • 66 77 300 and 66 77 400 Serial numbers (2743
  • 2852
  • 2854
  • 2855
  • 2856
  • 2858

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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