On Site Gas Systems POGS 33C Portable Oxygen System Recall
On Site Gas Systems is recalling 198 POGS 33C portable oxygen generation systems in Pennsylvania because the heat exchanger hose may fail.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II, and the defect involves a potential mechanical failure of a component in a medical device. No injuries or illnesses are reported, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
On Site Gas Systems Inc. is recalling 198 units of the POGS 33C Portable Oxygen Generation System. The recall is limited to units distributed in Pennsylvania.
The recall was initiated because the heat exchanger hose on these systems becomes weak and may fail. The source text does not report any injuries or illnesses associated with this defect.
Affected units have serial numbers ranging from 4220FA to 4418FA. Consumers should check their serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- On Site Gas Systems POGS 33C Portable Oxygen Generation System
- Manufacturer
- On Site Gas Systems Inc.
- Hazard
- Affected units
- 198
Distribution
Distributed in 1 state:
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