FDA-Device2018-01-31Class II
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Inovo, Inc
Hazard
Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).
Sold states
worldwide
Affected count
13,140 units
Manufactured in
401 Leonard Blvd N, N/A, Lehigh Acres, FL, United States
Products
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0407-2018Don't want to check this manually?
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