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

Recall Z-0008-2015 — Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for

U.S. FDA — Device Enforcement · United States · 2014-09-17 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0008-2015
Date of alert
2014-09-17
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Respironics California Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
123600002
Reported risk: A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia.
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.