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

Recall Z-1321-2023 — Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to

U.S. FDA — Device Enforcement · United Kingdom · 2023-02-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1321-2023
Date of alert
2023-02-23
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: During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.
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.