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Philips North America Recalls

530 recalls on record · April 5, 2017 to July 1, 2026 · Medical Devices

Recalls by year

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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

May 8, 2019Medical DevicesFDA
Philips North America, LLC recalls Fetal Spiral Electrode, Model No. 9898 031 37631
Hazard: During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.
April 17, 2019Medical DevicesFDA
Philips North America, LLC recalls Azurion FlexArm, 722079
Hazard: During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.
April 3, 2019Medical DevicesFDA
Philips North America, LLC recalls Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated fo
Hazard: Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturing defect that may affect the operation of the monitor
April 3, 2019Medical DevicesFDA
Philips North America, LLC recalls URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functiona
Hazard: The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
April 3, 2019Medical DevicesFDA
Philips North America, LLC recalls MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I univ
Hazard: The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
April 3, 2019Medical DevicesFDA
Philips North America, LLC recalls Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi
Hazard: The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
April 3, 2019Medical DevicesFDA
Philips North America, LLC recalls Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and
Hazard: The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
April 3, 2019Medical DevicesFDA
Philips North America, LLC recalls MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging applicatio
Hazard: The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
February 27, 2019Medical DevicesFDA
Philips North America, LLC recalls PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and including A.07.05.22 to eval
Hazard: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
February 27, 2019Medical DevicesFDA
Philips North America, LLC recalls PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the ele
Hazard: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
February 27, 2019Medical DevicesFDA
Philips North America, LLC recalls PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evalu
Hazard: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
February 27, 2019Medical DevicesFDA
Philips North America, LLC recalls PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including A.07.05.22 to eval
Hazard: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
February 27, 2019Medical DevicesFDA
Philips North America, LLC recalls PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05. 22 to evalu
Hazard: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
February 27, 2019Medical DevicesFDA
Philips North America, LLC recalls PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of
Hazard: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
February 27, 2019Medical DevicesFDA
Philips North America, LLC recalls PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of
Hazard: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
February 27, 2019Medical DevicesFDA
Philips North America, LLC recalls PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogra
Hazard: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
February 27, 2019Medical DevicesFDA
Philips North America, LLC recalls PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogra
Hazard: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
December 19, 2018Medical DevicesFDA
Philips North America LLC recalls HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/D
Hazard: Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer charge or deliver power to the Monitor/Defibrillator, which may prevent operation of the device if it is not connected to AC or DC power. Should a second, unaffected battery be present in the Monitor/Defibrillator, the battery failure may go unnoticed.
February 14, 2018Medical DevicesFDA
Philips North America, LLC recalls MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for
Hazard: Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.
April 5, 2017Medical DevicesFDA
Philips North America, LLC recalls HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M35
Hazard: HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring