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

Recall Z-2046-2018 — Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be us

U.S. FDA — Device Enforcement · United States · 2018-05-15 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2046-2018
Date of alert: 2018-05-15
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Draeger Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.

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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