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

Recall Z-0351-2014 — Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital envir

U.S. FDA — Device Enforcement · United States · 2013-10-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0351-2014
Date of alert: 2013-10-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Spacelabs Healthcare, Llc
Product category: device
Product type: Devices

Reported risk: Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component.

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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