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Patient Monitor
Guangdong Biolight Meditech Co., Ltd. · Model M9500 · UDI-DI 06932562310119
1
510(k) clearances
33,126
Adverse events (1,928 deaths)
294
Recalls
118
Facilities
Description
The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate(HR), Respiration Rate(RESP), Temperature(TEMP), Pulse Oxygen Saturation(BLT-SpO2), Pulse Rate(PR), Non-invasive Blood Pressure(NIBP), Invasive Blood Pressure( IBP) and Carbon dioxide(CO2) of adult, pediatric and neonatal patient.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-16 | Philips North America | Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity t |
| 2026-09-08 | Nihon Kohden America LLC | Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds |
| 2026-08-31 | 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 |
| 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 |
| 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 |
| 2026-07-31 | Philips North America | Due to software malfunction, patient information system may freeze and become unresponsive. |
| 2026-07-31 | Philips North America | Due to software malfunction, patient information system may freeze and become unresponsive. |
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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.