FDAClass IIApril 19, 2023

Digital VIPR ROC-9839 Roberts Oxygen Ready to Use recall

Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size…

Why was Digital VIPR ROC-9839 Roberts Oxygen Ready to Use recalled?

Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher than actual tank pressure. This may lead to tank running out of oxygen during use without audible alarms, potentially leading to an out of oxygen event and no flow.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

ROC-9839, Roberts Oxygen Ready to Use Digital VIPR (head only) o UDI-DI: B929ROC98390 ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) o UDI-DI: B929ROC98400 MNDR-600, Western Oxytote DTE Digital VIPR (head only) o UDI-DI: B929MNDR6000 MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) o UDI-DI: B929MNDS6020 MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder) o UDI-DI: B929MNDS6030 All units distributed from 05/29/2020 to 12/7/2022.

Product
Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size…
Recalling firm
Western/Scott Fetzer Company
Quantity
24,287 units
Distribution
US Nationwide distribution in the states of CO, CT, ID, MD, MT, TN, WA.
Recall date
April 19, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls