Modification of Apexpro Telemetry System

• • Ongoing Z-0175-2020 FDA Class II ·initiated 30 Aug 2019 ·on shared 510(k) K021325

  May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.

• • Terminated Z-0725-2020 FDA Class II ·initiated 12 Nov 2019 ·on shared 510(k) K021325

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K021325 ↗

FDA Product Code

MHX

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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