FDA-Device2022-06-29Class I
Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
Getinge Usa Sales Inc
Hazard
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
Sold states
US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia
Affected count
47 units US
Manufactured in
1 Geoffrey Way, Wayne, NJ, United States
Products
Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1279-2022Don't want to check this manually?
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