Agency classClass IOur severity:Severe FDA (Devices)·Z-1279-2022·Announced 2022-06-29

Anesthesia system suction switch may crack and fail to activate

Getinge Flow-e Anesthesia System units may have a crack forming on the suction unit's on/off switch, which could break and prevent the suction from being activated, potentially harming patients.

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 FDA classified this as a Class I recall, the highest category for medical device defects, establishing a minimum severity of 4. No illnesses or injuries have been reported, but the potential inability to activate the suction unit during anesthesia procedures poses a serious risk of patient harm.

Plain-English summary

The Getinge Flow-e Anesthesia System is a medical device used to administer anesthesia while controlling patient ventilation. A Class I recall has been issued for 47 units that were distributed to healthcare facilities in Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia.

The recalled units have a defect affecting the on/off switch of the suction unit. According to the FDA, the switch may develop a crack that could cause it to break. If the switch breaks, the suction unit cannot be activated, creating an unreasonable risk of harm to patients during anesthesia procedures.

Healthcare facilities with affected units should contact Getinge Usa Sales Inc. All 47 affected units are identified by specific serial numbers documented in the FDA recall notice. No injuries or illnesses have been reported in connection with this defect.

The recalled product

Product: Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
Manufacturer: Getinge Usa Sales Inc
Category: Medical Device — Anesthesia System
Hazard: switch-defect
equipment-failure
Affected units: 47

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 (20)

UDI-DI: 07325710010457 Serial Numbers: 50012
50013
50014
50015
50016
50017
50030
50031
50033
50034
50035
50036
50037
50038
50039
50040
50041
50042
50043
50046

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 2 recalled by Getinge Usa Sales Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Getinge Usa Sales Inc

See all →

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Same hazard · switch defect