FDA Device Intelligence
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Alarm, Blood-Pressure

FDA product code DSJ · Class 2 · Cardiovascular

63
Registered devices
120
Adverse events
4
Recalls
6
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2023-08-31Philips North America LlcA software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
2023-08-31Philips North America LlcA software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
2023-03-06Philips North America LlcEarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failur
2023-03-06Philips North America LlcEarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failur

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.