eCareManager 4.6Recalls & reported problems
Visicu, Inc. · Telehealth Center Product License · Class 2
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jan 3, 2022Terminated
eCareManager (eCM) Sentry Score software not approved for use
Z-0549-2022 · Root cause: Under Investigation by firm · FDA record ↗
Other System, network and communication, physiological monitors devices
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- CareEventPhilips Medical Systems Hsg · System, network and communication, physiological monitors2 recalls4 deaths7 reports
- XTR 96280Spacelabs Healthcare (Washington), Inc · SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS2 recalls0 reports
- CNS-2101 Central MonitorNihon Kohden Corporation · System, Network And Communication, Physiological Monitors3 deaths76 reports
- BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · System, Network And Communication, Physiological Monitors1 recall2 deaths5 reports
- eCareManager 4.5Visicu, Inc. · System, network and communication, physiological monitors1 recall1 death1 report
- eCareManager 4.3Visicu, Inc. · System, network and communication, physiological monitors1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.