FDA Device Intelligence
Home › MASIMO CORPORATION › Radius VSM

Radius VSM

MASIMO CORPORATION · Model 9033 · UDI-DI 00843997016377

MHX Prescription
1
510(k) clearances
32,636
Adverse events (1,917 deaths)
293
Recalls
118
Facilities

Description

Radius VSM Kit

Recalls

DateFirmReason
2026-09-08Nihon Kohden America LLCDue to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds
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
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
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
2026-07-31Philips North AmericaDue to software malfunction, patient information system may freeze and become unresponsive.
2026-07-31Philips North AmericaDue to software malfunction, patient information system may freeze and become unresponsive.
2026-06-05Philips North America LlcPotential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PI

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.