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Recall Observatory FDA recall evidence

Device product

PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S

Z-0407-2018

October 09, 2017

Class II

Product summary

Firm
Inovo, Inc
Event
Event 78883
Status
Terminated
Classification
Class II
Quantity
13,140 units
Official record key
device-enforcement:Z-0407-2018

Official wording

Reason: 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).

Code information: UDI #(s): 00814470020013 (model CHSOOO) and 00814470020006 (model CHSOOOS): All serial numbers

Distribution pattern: worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).