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

Recall Z-0726-2020 — CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to colle

U.S. FDA — Device Enforcement · United States · 2019-11-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0726-2020
Date of alert: 2019-11-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare, LLC
Product category: device
Product type: Devices

Reported risk: When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information Center (CIC) systems were identified to have vulnerabilities to a cyber-attack.

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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