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

Recall Z-2077-2019 — PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents th

U.S. FDA — Device Enforcement · United States · 2019-06-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2077-2019
Date of alert: 2019-06-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GETINGE US SALES LLC
Product category: device
Product type: Devices

Reported risk: The monitor displays an error message . The error message states "internal error restart or service".

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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