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

Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044 — recall Z-2625-2023

U.S. FDA — Device Enforcement · United Kingdom · 2023-08-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2625-2023
Date of alert
2023-08-24
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: Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/restart are required. Error prevents: viewing graphical patient vital signs, sounding of pulse audio tone, visualization of patient airway used during intubation; may lead to treatment delay or hypoxia.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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