Devices

Device Recall System O2 Portable Oxygen Delivery System (PODS).

Model / Serial
All units are under recall.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Units were sent to 2 direct distributors located in GA.
Product Description
System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 6 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Box Includes Delivery system with Clear Base. 4 White Powder refills. 4 Black Powder refills. Water bottle. Nasal cannula. Medium concentration mask. Carry Case. Operating Instructions xxx, Directions: xxx, Caution: Federal Law (USA) restricts this device to sale by or on the order of a licensed physician.xxx, Applications: Unit is intended to provide oxygen for emergency use. Manufactured by System O2, Inc., 1090 Upper Hembree Road, Roswell, GA 30076-1140.
Manufacturer
System 02 Inc
1 Event
- Recall of Device Recall System O2 Portable Oxygen Delivery System (PODS).

Manufacturer

System 02 Inc

Manufacturer Address
System 02 Inc, 1090 Upper Hembree Rd, Roswell GA 300761140
Source
USFDA

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