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

Recall Z-1548-2014 — Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2)

U.S. FDA — Device Enforcement · United States · 2014-04-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1548-2014
Date of alert: 2014-04-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare
Product category: device
Product type: Devices

Reported risk: Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.

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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