Manufacturer

Philips North America, LLC

410 recalls in our database name Philips North America, LLC as the manufacturing or recalling firm.

What the numbers show

Total: 410
Critical: 2
Severe: 26
Most recent: 2026-09-09

Of the 410 recalls from Philips North America, LLC we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 26 (6%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

376–400 of 410

SevereFDA (Devices)·Z-1923-2019·2019-07-17
Philips HeartStart MRx Recall Due to AC Power Module Failure Risk
Philips is recalling HeartStart MRx devices used with specific AC power modules that may fail, potentially causing loss of power and failure to deliver shocks.
Product
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1772-2019·2019-06-19
Philips IntelliBridge System Recall for Infusion Pump Data Storage Accuracy Issues
Philips is recalling IntelliBridge Systems configured with comma decimal separators because infusion pump data may be recorded at 100 times the actual values.
Product
Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator: 866417 IntelliBridge System C.01 (or later) 866418 IntelliBridge System C.01 upgrade (or later) Product Usage: The IntelliBridge System is indicated for use in data
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1771-2019·2019-06-19
Philips Patient Information Center iX Recall for Infusion Pump Data Accuracy
Philips is recalling Patient Information Center iX software because infusion pump data may be recorded at 100 times the actual rate.
Product
Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the I
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1693-2019·2019-06-12
Philips IntelliVue MX40 Patient Monitor Recalled for Battery Issues
Philips is recalling IntelliVue MX40 Patient Monitors because they may consume excess power and fail to provide visual or audible low-battery alerts.
Product
IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467821, 453564467841, 453564467861, 453564262531, and 453564262551 - Product Usage
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1692-2019·2019-06-12
Philips IntelliVue MX40 Patient Monitor Recalled for Battery Defect
Philips is recalling IntelliVue MX40 Patient Monitors because they may experience increased power consumption and lack visual or audible notifications when in a low battery state.
Product
IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connecte
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1695-2019·2019-06-12
Philips IntelliVue MX40 Patient Monitor Recalled for Battery Notification Defects
Philips is recalling IntelliVue MX40 Patient Monitors because they may fail to provide visual or audible alerts when the battery is low.
Product
IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is c
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1694-2019·2019-06-12
Philips IntelliVue MX40 Patient Monitor Recalled for Battery Notification Issues
Philips is recalling IntelliVue MX40 Patient Monitors because they may fail to provide visual or audible low-battery alerts, potentially disrupting patient monitoring.
Product
IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371 Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1322-2019·2019-05-22
Philips SureSigns VS3 Monitor Software Defect Recall
Philips is recalling SureSigns VS3 patient monitors because a software defect prevents the device from measuring or alarming for pulse rates above 240 beats per minute.
Product
SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1319-2019·2019-05-22
Philips SureSigns VS3 Monitor Recall for High Pulse Rate Measurement Failure
Philips is recalling SureSigns VS3 monitors because a software defect prevents the device from measuring, displaying, or alarming for pulse rates above 240 beats per minute.
Product
SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1321-2019·2019-05-22
Philips SureSigns VS3 Monitor Recall Due to Software Defect
Philips is recalling SureSigns VS3 monitors because a software defect prevents the device from measuring, displaying, or alarming for pulse rates above 240 beats per minute.
Product
SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1323-2019·2019-05-22
Philips SureSigns VS4 Monitor Software Defect Recall
Philips is recalling SureSigns VS4 monitors because software prevents the device from measuring or alarming for pulse rates above 240 beats per minute.
Product
SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1320-2019·2019-05-22
Philips SureSigns VS3 Monitor Software Defect Recall
Philips is recalling 3,177 SureSigns VS3 monitors because a software defect prevents the device from measuring, displaying, or alarming for pulse rates above 240 beats per minute.
Product
SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1324-2019·2019-05-22
Philips SureSigns VS4 Monitor Software Defect Recall
Philips is recalling 366 SureSigns VS4 monitors because software prevents the device from measuring or alarming for pulse rates above 240 beats per minute.
Product
SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1317-2019·2019-05-22
Philips SureSigns VS3 NBP Recall for Pulse Rate Measurement Limitation
Philips is recalling SureSigns VS3 NBP monitors because software prevents the display and alarm for pulse rates above 240 beats per minute.
Product
SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1318-2019·2019-05-22
Philips SureSigns VS3 Monitor Software Defect Recalled
Philips is recalling 518 SureSigns VS3 monitors because a software defect prevents the device from measuring or alarming for pulse rates above 240 beats per minute.
Product
SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1250-2019·2019-05-08
Philips Fetal Spiral Electrode Recall Due to Metal Tip Breakage Risk
Philips is recalling Fetal Spiral Electrodes because the metal tip may break off and remain in a newborn's scalp during delivery.
Product
Fetal Spiral Electrode, Model No. 9898 031 37631
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1130-2019·2019-04-17
Philips Recalls Two Azurion FlexArm Units Due to Cable Damage
Philips is recalling two Azurion FlexArm units because a manufacturing error caused damage to the 24V power cable of the detector.
Product
Azurion FlexArm, 722079
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1053-2019·2019-04-03
Philips UroDiagnost MRF Recall Due to Missing Locking Plate
Philips is recalling UroDiagnost MRF units because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.
Product
Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition cyst
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1056-2019·2019-04-03
Philips URODiagnost Eleva X-ray System Recalled for Missing Locking Plate
Philips North America, LLC is recalling URODiagnost Eleva X-ray systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.
Product
URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1054-2019·2019-04-03
Philips OmniDiagnost X-ray System Recalled for Missing Locking Plate
Philips North America is recalling 1,696 OmniDiagnost Classic X-ray systems because a missing locking plate may cause unexpected stand or table movement that users cannot stop.
Product
Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1052-2019·2019-04-03
Philips MultiDiagnost-Eleva Imaging System Recalled for Missing Locking Plate
Philips is recalling MultiDiagnost-Eleva imaging systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.
Product
MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1055-2019·2019-04-03
Philips MultiDiagnost Eleva Imaging System Recalled for Missing Locking Plate
Philips is recalling MultiDiagnost Eleva imaging systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.
Product
MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1067-2019·2019-04-03
Philips MX40 Wearable Monitor Batteries Recalled for Manufacturing Defect
Philips North America is recalling 40 lithium-ion rechargeable batteries for the MX40 Wearable Monitor due to a manufacturing defect that may affect monitor operation.
Product
Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, a
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0860-2019·2019-02-27
Philips PageWriter TC50 Recall for Battery Overheating and Ignition Risk
Philips is recalling PageWriter TC50 devices because end-of-life batteries may overheat, melt, or ignite, posing injury risks to patients and users.
Product
PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0858-2019·2019-02-27
Philips PageWriter TC Cardiograph Recall for Battery Overheating and Fire Risk
Philips is recalling PageWriter TC70 cardiographs because end-of-life batteries may overheat, melt, or ignite, posing injury risks to patients and users.
Product
PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Category
Medical Device
Distribution
Distributed nationwide