Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Cardiovascular · 21 CFR 870.1025
Recent MDR events
32,228 adverse event reports on file
- Xhibit Central StationJul 31, 2026MalfunctionSpacelabs Healthcare3010157426-2026-00124
- IntelliVue Multi-Measurement Module X3Jul 31, 2026MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2026-101555
- uCor Heart Failure and Arrhythmia Management SystemJul 31, 2026InjuryZoll Manufacturing Corporation3008642652-2026-07381
- Tempus Pro, PrinterJul 31, 2026MalfunctionRemote Diagnostic Technologies Ltd.3003832357-2026-100443
- Patient Information Center iXJul 31, 2026DeathPhilips Medizin Systeme Böblingen Gmbh9610816-2026-101556
- Patient Information Center iXJul 31, 2026MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2026-101557
- IntelliVue MX40 2.4GHzJul 31, 2026MalfunctionPhilips Medical Systems1218950-2026-100528
- IntelliVue Multi-Measurement Module X3Jul 31, 2026MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2026-101559
- Tempus Pro, Printer, IBPJul 31, 2026MalfunctionRemote Diagnostic Technologies Ltd.3003832357-2026-100444
- IntelliVue MX40 WLANJul 31, 2026MalfunctionPhilips Medical Systems1218950-2026-100529
Event type breakdown
Recalls
283 recall events for this product code
- Spacelabs Healthcare, Inc.Open, ClassifiedAug 7, 2026
Brand Name: Xhibit
Due to off-the-shelf display port component that has audio/video failures
Z-2916-2026 · View FDA record ↗ - Masimo CorporationOpen, ClassifiedJul 2, 2026
Radius VSM ECG pre-connected Set, REF: 4842, 4695
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
Z-2670-2026 · View FDA record ↗ - Masimo CorporationOpen, ClassifiedJul 2, 2026
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
Z-2671-2026 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedJun 24, 2026
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Mo
Potential 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 PIC iX central monitoring system.
Z-2579-2026 · View FDA record ↗ - GE Medical Systems Information Technologies IncOpen, ClassifiedMay 28, 2026
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Z-2242-2026 · View FDA record ↗ - GE Medical Systems Information Technologies IncOpen, ClassifiedMay 28, 2026
GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (C
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Z-2243-2026 · View FDA record ↗ - GE Medical Systems Information Technologies IncOpen, ClassifiedMay 28, 2026
GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiolog
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Z-2244-2026 · View FDA record ↗ - GE Medical Systems Information Technologies IncOpen, ClassifiedMay 28, 2026
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Z-2245-2026 · View FDA record ↗ - GE Medical Systems Information Technologies IncOpen, ClassifiedMay 28, 2026
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Tele
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Z-2246-2026 · View FDA record ↗ - GE Medical Systems Information Technologies IncOpen, ClassifiedMay 28, 2026
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor,
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Z-2247-2026 · View FDA record ↗
Registered firms
561 firms currently registered for this product code
Gww
Gaertringen Baden-Wurttemberg, DE
Philips North America Llc
Cambridge, MA, US
Zoll Manufacturing Corporation
Pittsburgh, PA, US
Mainline Medical Dental Supply
North York Ontario, CA
Amphenol Medical Technologies (dongguan) Co., Ltd.
Dongguan Guangdong, CN
Technical Services For Electronics, Inc.
New Taipei City, TW
Nihon Kohden Corporation - Tokorozawa Establishment Advanced Technology Center
Tokorozawa Saitama, JP
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
Criticare Technologies, Inc.
Warwick, RI, US
Ge Healthcare Finland Oy
HELSINKI Uusimaa, FI
Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI, US
Respironics Novametrix, Llc
Andover, MA, US
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Shenzhen Guangdong, CN
Jpex Medical Equipment & Supplies, Inc.
Ronkonkoma, NY, US
510(k) clearances
427 clearances for this product code
- Edan Instruments, Inc.Aug 6, 2026
K251508 · Telemetry Monitor (iT30, iT50)
- Ge Medical Systems Information Technologies, Inc.Jul 24, 2026
K253277 · Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
- Masimo CorporationJun 4, 2026
K254209 · Radius VSM and Accessories
- Global Instrumentation, LLCMay 29, 2026
K252840 · M12 Telemetry System
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.May 20, 2026
K260098 · ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)
- Shanghai Draeger Medical Instrument Co., Ltd.Apr 24, 2026
K250349 · Vista CMS
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Apr 16, 2026
K253170 · uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
- Shanghai Draeger Medical Instrument Co., Ltd.Apr 10, 2026
K252250 · Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)