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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- switch-defect
- equipment-failure
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
Distribution scope not specified by the agency.
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