SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the Si

FDA device recall Z-0481-2026 · posted 2025-11-07 · Open, Classified

Recall details

Recalling firm

Philips Respironics, Inc.

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.

Action taken

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 immediately. Contact your distributor and follow their instructions on how to receive a replacement battery and arrange for the return of the affected batteries in your possession. If the serial number on your battery kit does not match any of the affected serial numbers, then your battery is not affected by this issue and there is no need for any further action by you.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

CAW

Quantity affected

56 units (55 US, 1 OUS)

Distribution

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

Date initiated

2025-10-07

Date posted

2025-11-07

Location

Murrysville, PA