FDA-Device2025-11-19Class IIPROCESSING DEFECT
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600
Hazard
Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country of Canada.
Affected count
56 units (55 US, 1 OUS)
Manufactured in
1001 Murry Ridge Ln, Murrysville, PA, United States
Products
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0481-2026Want us to check the next one for you?
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