[pending] SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold a
Pending LLM rewrite. Source: FDA_DEVICE Z-0481-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- 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
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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