Philips Respironics, Inc. — SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Conc
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 7, 2025
US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country of Canada.
What's affected?
- Product
- 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
- Lot code
- Product Code: 1116816; UDI-DI: 00606959032385; Serial Numbers: 2438V115830, 2438V115960, 2438V116033, 2438V115899, 2438V115832, 2438V115964, 2438V116034, 2438V115837, 2438V115965, 2438V116040, 2438V115840, 2438V115967, 2438V116044, 2438V115842, 2438V115968, 2438V116045, 2438V115844, 2438V115970, 2438V116046, 2438V115878, 2438V115972, 2438V116047, 2438V115890, 2438V115973, 2438V116048, 2438V115894, 2438V115974, 2438V116049, 2438V115895, 2438V115980, 2438V116050, 2438V115896, 2438V115981, 2438V116051, 2438V115897, 2438V115983, 2438V116052, 2438V115919, 2438V115984, 2438V116226, 2438V115937, 2438V115991, 2438V116229, 2438V115939, 2438V115992, 2438V116233, 2438V115942, 2438V115993, 2438V116249, 2438V115948, 2438V115994, 2438V116253, 2438V115957, 2438V115995, 2438V116258, 2438V117762;
Additional details
Product Code: 1116816; UDI-DI: 00606959032385; Serial Numbers: 2438V115830, 2438V115960, 2438V116033, 2438V115899, 2438V115832, 2438V115964, 2438V116034, 2438V115837, 2438V115965, 2438V116040, 2438V115840, 2438V115967, 2438V116044, 2438V115842, 2438V115968, 2438V116045, 2438V115844, 2438V115970, 2438V116046, 2438V115878, 2438V115972, 2438V116047, 2438V115890, 2438V115973, 2438V116048, 2438V115894, 2438V115974, 2438V116049, 2438V115895, 2438V115980, 2438V116050, 2438V115896, 2438V115981, 2438V116051, 2438V115897, 2438V115983, 2438V116052, 2438V115919, 2438V115984, 2438V116226, 2438V115937, 2438V115991, 2438V116229, 2438V115939, 2438V115992, 2438V116233, 2438V115942, 2438V115993, 2438V116249, 2438V115948, 2438V115994, 2438V116253, 2438V115957, 2438V115995, 2438V116258, 2438V117762;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 56 units (55 US, 1 OUS).
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