Alarm, Blood-pressure
Cardiovascular · 21 CFR 870.1100
Recent MDR events
120 adverse event reports on file
- SURESIGNS VS3 NBP, SPO2Jul 9, 2026MalfunctionPhilips Medical Systems1218950-2026-100479
- SURESIGNS VS3 NBP, SPO2Jul 1, 2026MalfunctionPhilips Medical Systems1218950-2026-100459
- SURESIGNS VS3 NBP, SPO2Mar 17, 2026MalfunctionPhilips Medical Systems1218950-2026-100140
- SURESIGNS VS3 NBP, SPO2Aug 5, 2025MalfunctionPhilips Medical Systems1218950-2025-000446
- EARLYVUE VS30 VITAL SIGNS MONITORMay 30, 2025MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2025-000450
- EARLYVUE VS30 VITALS MONITORMay 9, 2025MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2025-000401
- EARLYVUE VS30 VITALS MONITORApr 30, 2025MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2025-000373
- EARLYVUE VS30 VITAL SIGNS MONITORApr 22, 2025MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2025-000332
- EARLYVUE VS30 VITALS MONITORFeb 4, 2025MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2025-000075
- EARLYVUE VS30 VITAL SIGNS MONITORJan 16, 2025MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2025-000035
Event type breakdown
Recalls
4 recall events for this product code
- Philips North America LlcOpen, ClassifiedSep 29, 2023
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Z-2654-2023 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedSep 29, 2023
EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Z-2655-2023 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedMay 26, 2023
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01
EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition.
Z-1644-2023 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedMay 26, 2023
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01
EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition.
Z-1645-2023 · View FDA record ↗
Registered firms
174 firms currently registered for this product code
Gww
Gaertringen Baden-Wurttemberg, DE
Philips North America Llc
ANDOVER, MA, US
Philips North America Llc
Cambridge, MA, US
Ge Medical Systems Information Technologies
EL PASO, TX, US
Ge Medical Systems (china) Co., Ltd.
WUXI Jiangsu, CN
Philips Medizin Systeme Boeblingen Gmbh
BOEBLINGEN Baden-Wurttemberg, DE
Ge Healthcare Finland Oy
HELSINKI Uusimaa, FI
Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI, US
Philips North America Llc
Export, PA, US
Masimo Corporation
Irvine, CA, US
Philips North America Llc
Murrysville, PA, US
Philips Electronics Ltd
Mississauga Ontario, CA
Amphenol Medical Technologies (dongguan) Co., Ltd.
Dongguan Guangdong, CN
Ge Medical Systems Information Technologies - Critikon De Mexico S. De R.l. De C.v.
JUAREZ Chihuahua, MX
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Shenzhen Guangdong, CN
Dhl Supply Chain (netherlands) B.v.
Beringe Limburg, NL
Philips Goldway (shenzhen) Industrial Inc.
SHENZHEN Guangdong, CN
510(k) clearances
6 clearances for this product code
- Philips Medizin Systeme Boeblingen GmbHOct 27, 2019
K190624 · EarlyVue VS30
- Philips Medical SystemsMar 31, 2017
K163649 · SureSigns VS3; SureSigns VS4
- Phillips Medical SystemsSep 29, 2015
K151761 · SureSigns VS3, SureSigns VS4
- Philips Medical SystemsJun 26, 2014
K133961 · SURESIGNS VS3, SURESIGNS VS4
- 3M Health Care, SarnsJun 4, 1996
K960916 · SAMS 8000 CARDIOPLEGIA MONITOR
- Keller Medical Specialties Products, Inc.Apr 1, 1991
K910262 · KELLER VITAL SIGNS MONITOR - KMS-890