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

Recall Z-2115-2018 — Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG

U.S. FDA — Device Enforcement · United States · 2017-11-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2115-2018
Date of alert: 2017-11-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Invivo Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 453564428541

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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.

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