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

Recall Z-0095-2019 — GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CA

U.S. FDA — Device Enforcement · Finland · 2018-09-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0095-2019
Date of alert: 2018-09-04
Country / jurisdiction: Finland
Risk level: Class II
Risk type: recall
Brand: GE Healthcare Finland Oy
Product category: device
Product type: Devices

Reported risk: When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.

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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