# FDA recall Z-0407-2018

> **Inovo, Inc** · Class II · device recall initiated 2017-10-09.

## Product

PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S

## Reason for recall

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).

## Distribution

worldwide

## Key facts

- **Recall number:** Z-0407-2018
- **Recalling firm:** Inovo, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-09
- **Report date:** 2018-01-31
- **Termination date:** 2023-09-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lehigh Acres, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0407-2018

## Citation

> AI Analytics. FDA recall Z-0407-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0407-2018. Source: US FDA. Licensed CC0.

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