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eCareManager
VISICU, INC. · Model 4.6 · UDI-DI 00884838106963
MSX
Prescription
1
510(k) clearances
320
Adverse events (96 deaths)
21
Recalls
73
Facilities
Description
Telehealth Center Product License
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-18 | Mindray DS USA, Inc. dba Mindray North America | When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing. |
| 2024-02-28 | Philips North America | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode. |
| 2022-01-03 | Philips North America Llc | eCareManager (eCM) Sentry Score software not approved for use |
| 2021-05-27 | Mindray DS USA, Inc. dba Mindray North America | Telepack may not power on when using the 3AA battery cradle. |
| 2021-02-22 | Mindray DS USA, Inc. dba Mindray North America | BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If a freeze occur, patients monitored on a telemetry transmitter will no |
| 2018-01-17 | Spacelabs Healthcare Inc | Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring. |
| 2017-09-28 | Philips Electronics North America Corporation | Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram |
| 2017-07-14 | Mindray DS USA, Inc. dba Mindray North America | A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate. |
| 2015-12-10 | Ascom US, INC. | Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected |
| 2015-11-08 | Vidco, Inc. | Testing at customer site showed unit Remote Patient Monitoring System MDP2040-0100 in a continuous trap condition, not allowing system to reset and reboot. Two customers recently |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.