Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1376-2023 — 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,

U.S. FDA — Device Enforcement · United States · 2023-01-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1376-2023
Date of alert: 2023-01-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Western/Scott Fetzer Company
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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