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BluPRO®

NIHON KOHDEN CORPORATION · Model TL-272T · UDI-DI 14931921874261

MHXDRG Prescription
10
510(k) clearances
32,636
Adverse events (1,917 deaths)
293
Recalls
118
Facilities

Description

SpO2 probe Child (from 10 to 50 kg) Finger or toe, disposable

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

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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.