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

Recall Z-1767-2020 — TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951

U.S. FDA — Device Enforcement · United States · 2020-03-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1767-2020
Date of alert
2020-03-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
453564007261
Reported risk: The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a Philips Patient Information Center iX Release C.02.xx or C.03.01. If this occurs, the Information Center will not display a heart rate or generate, display or annunciate any heart rate or arrhythmia alarms.
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.