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

Recall Z-1997-2021 — Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).

U.S. FDA — Device Enforcement · United Kingdom · 2021-05-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1997-2021
Date of alert
2021-05-25
Country / jurisdiction
United Kingdom
Risk level
Class II
Risk type
recall
Brand
Remote Diagnostic Technologies Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05060472440020
Reported risk: The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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