SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for th
Summary
The FDA issued a Class II for SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected bat by Philips Respironics, Inc.. 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 .
Details
Source
Device Recall
External ID
Z-0481-2026
Action Date
2025-11-19
Status
Ongoing
Category
device
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
Lot/Code Info: 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;
Quantity Affected: 56 units (55 US, 1 OUS)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-07
Company
Murrysville, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 148 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Philips Respironics, Inc. has 74 FDA actions in our database, including 74 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Respironics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Respironics, Inc. have FDA actions?
Philips Respironics, Inc. has 74 FDA actions in our database, including 74 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0481-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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