Recall Z-0481-2026 ยท CAW Generator, Oxygen, Portable
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 Concentrator Product code: 1113600
| Date | Nov 7, 2025 (initiated Oct 7, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | On October 7, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions for Distributors: Check inventory and place into quarantine any identified affected products. Complete and return the provided response form. Alert any customers who may have purchased affected products and work with them to return the affected product. A Philips representative will reach out regarding return and replacement of all affected product. Actions for patients: Check the serial numbers to verify if product affected by recall. If your product is affected, please discontinue use or the battery immed |
| Quantity | 56 units (55 US, 1 OUS) |
| Distribution | US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.