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

Recall Z-1729-2025 — Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

U.S. FDA — Device Enforcement · United Kingdom · 2025-04-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1729-2025
Date of alert
2025-04-15
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: Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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