Inovo, Inc: PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S

Is my product affected?

PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S

• UPC 00814470020013
• UPC 00814470020006

Check against the official notice below — it lists the full affected range.

What happened

Inovo, Inc. is recalling 13,140 units of its PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S worldwide due to a hazard involving low oxygen purity. Post-market surveillance data shows that these devices have a complaint and service rate greater than 35% for producing oxygen output below the published specifications.

The affected devices include all serial numbers of Model CH5000 (UDI #00814470020013) and Model CH5000S (UDI #00814470020006). The source document does not specify a remedy or instructions for what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

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).

Details from the source

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 Quantity: 13,140 units Lot/code info: UDI #(s): 00814470020013 (model CHSOOO) and 00814470020006 (model CHSOOOS): All serial numbers

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled 2017-10-11
• VITEK2 GP-ID, REF 21342 IVD2017-10-11
• 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.2017-10-05
• MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.2017-10-14
• Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology mo2017-10-02

All FDA (Device enforcement) recalls