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BeneVision Central Monitoring System

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Model BeneVision · UDI-DI 06944904055299

MSX Prescription
2
510(k) clearances
324
Adverse events (97 deaths)
23
Recalls
73
Facilities

Recalls

DateFirmReason
2026-08-31Mindray DS USA, Inc.Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31Mindray DS USA, Inc.Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2025-11-18Mindray DS USA, Inc. dba Mindray North AmericaWhen the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
2024-02-28Philips North AmericaIt 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.
2022-01-03Philips North America LlceCareManager (eCM) Sentry Score software not approved for use
2021-05-27Mindray DS USA, Inc. dba Mindray North AmericaTelepack may not power on when using the 3AA battery cradle.
2021-02-22Mindray DS USA, Inc. dba Mindray North AmericaBeneVision 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
2018-01-17Spacelabs Healthcare IncSpacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.
2017-09-28Philips Electronics North America CorporationPhilips 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
2017-07-14Mindray DS USA, Inc. dba Mindray North AmericaA damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate.

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Data 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.