FDA recall Z-0481-2026

Philips Respironics, Inc. · Class II · device

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

Reason for recall

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.

Distribution

US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country of Canada.

Key facts

Status: Ongoing
Initiation date: 2025-10-07
Report date: 2025-11-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Murrysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0481-2026