Device product
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Z-1369-2022
Product summary
- Event
- Event 90108
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 179 devices
- Official record key
device-enforcement:Z-1369-2022
Official wording
Reason: Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
Code information: UDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX
Distribution pattern: Domestic distribution to the following states: ALASKA ARIZONA CALIFORNIA COLORADO GEORGIA IDAHO IOWA KANSAS KENTUCKY MICHIGAN MINNESOTA MISSOURI NEW YORK NORTH CAROLINA OHIO OKLAHOMA PENNSYLVANIA TENNESSEE
Derived failure modes
-
Unknown
Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.