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

Recall Z-2380-2012 — Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients.

U.S. FDA — Device Enforcement · United States · 2012-06-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2380-2012
Date of alert: 2012-06-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zoe Medical Incorporated
Product category: device
Product type: Devices

Reported risk: Unit fails to power up, resulting in an equipment alarm

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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