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

Recall Z-3192-2018 — Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388

U.S. FDA — Device Enforcement · United States · 2018-08-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3192-2018
Date of alert
2018-08-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Invivo Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
453564669081
Reported risk: Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate heart rate (HR) displayed due to QRS detection fault.
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.