Medical device recalls Moderate risk

Western/Scott Fetzer Company recalls Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digita…

Recall date
January 3, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1376-2023
FDA classification
Class II
Brand / firm
Western/Scott Fetzer Company
Sold / distributed
US Nationwide distribution in the states of CO, CT, ID, MD, MT, TN, WA.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder)

Get recall alerts

Free email alert whenever Western/Scott Fetzer Company has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Western/Scott Fetzer Company