Recall Z-0481-2026— Philips Respironics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Philips Respironics, Inc., initiated 2025-10-07. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Philips Respironics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-07
- Firm location
- Murrysville, PA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.