Home › Device types › MSX
System, Network And Communication, Physiological Monitors
FDA product code MSX · Class 2 · Cardiovascular
298
Registered devices
325
Adverse events
23
Recalls
121
510(k) clearances
Devices with this code
PORTRAIT SpO2 P-SA01 — GE Healthcare Finland OyAvalon Toco+ Transducer — Philips Medizin Systeme Böblingen GmbH5-Lead,New Telemetry,AHA,Pinch,24″ — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.TigerConnect Alarm Management — Critical AlertZOLL RescueNet Link — Zoll Medical CorporationPortrait CSSXB — GE Medical Systems Information Technologies, Inc.LIFENET Connect Gateway — PHYSIO-CONTROL, INC.Care Assist — Philips Medizin Systeme Böblingen GmbHRescueNet 12-Lead — Zoll Medical CorporationLIFENET CONSULT INTERNATIONAL — PHYSIO-CONTROL, INC.Care Assist — Philips Medizin Systeme Böblingen GmbH5-Lead,New Telemetry,IEC,Snap,36″ — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CS host package (2U Rack) — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.PORTRAIT BCH01 — GE Healthcare Finland OyCMSViewer CD(review FDA) — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.eCareManager — VISICU, INC.Care Assist — Philips Medizin Systeme Böblingen GmbHCare Assist — Philips Medizin Systeme Böblingen GmbHTransmitter — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CareEvent — Philips Medical Systems HsgCurrent Health Wearable Monnitoring System — CURRENT HEALTH LIMITEDXhibit Telemetry Receiver — SPACELABS HEALTHCARE (WASHINGTON), INCSpacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INC0155 Signal Converter Package — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-31 | Mindray DS USA, Inc. | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| 2026-08-31 | Mindray DS USA, Inc. | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| 2025-11-18 | 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 pass |
| 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 |
| 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 |
| 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. |
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