Philips Medical Systems recalls

Philips Medical Systems appears in 81 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O
  FDA Device · Class II · 2014-11-19 · Philips Medical Systems
  Reason: Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
• Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A
  FDA Device · Class II · 2014-10-29 · Philips Medical Systems
  Reason: Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
• Philips IntelliVue Monitors with software revisions J.21.03, J.21.19
  FDA Device · Class II · 2014-10-29 · Philips Medical Systems
  Reason: Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
• Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
  FDA Device · Class II · 2014-10-15 · Philips Medical Systems
  Reason: Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
• Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System
  FDA Device · Class II · 2014-08-27 · Philips Medical Systems
  Reason: Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient record to contain multiple and therefore inaccurate patient id…
• Ingenia 1.5T, magnetic resonance imaging system
  FDA Device · Class II · 2014-07-02 · Philips Medical Systems
  Reason: For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
• Ingenia 1.5T R5, magnetic resonance imaging system
  FDA Device · Class II · 2014-07-02 · Philips Medical Systems
  Reason: For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
• Ingenia 3.0T R5, magnetic resonance imaging system
  FDA Device · Class II · 2014-07-02 · Philips Medical Systems
  Reason: For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
• Ingenia 3.0T, magnetic resonance imaging system
  FDA Device · Class II · 2014-07-02 · Philips Medical Systems
  Reason: For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
• Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System
  FDA Device · Class II · 2014-06-25 · Philips Medical Systems
  Reason: Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.
• Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System
  FDA Device · Class II · 2014-06-25 · Philips Medical Systems
  Reason: Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.
• IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX)
  FDA Device · Class II · 2014-06-18 · Philips Medical Systems
  Reason: IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.
• Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors
  FDA Device · Class II · 2014-05-28 · Philips Medical Systems
  Reason: The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Such failure can result in overheating that in rare cases can c…
• Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distribu…
  FDA Device · Class II · 2014-04-30 · Philips Medical Systems
  Reason: Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations
• Digital Diagnost, stationary radiographic system
  FDA Device · Class II · 2014-04-30 · Philips Medical Systems
  Reason: The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held.
• Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator
  FDA Device · Class II · 2014-04-16 · Philips Medical Systems
  Reason: A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy
• Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external de…
  FDA Device · Class II · 2014-04-16 · Philips Medical Systems
  Reason: Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy.
• Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for the te…
  FDA Device · Class II · 2014-03-19 · Philips Medical Systems
  Reason: When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.
• Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
  FDA Device · Class II · 2014-03-19 · Philips Medical Systems
  Reason: MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing
• Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
  FDA Device · Class II · 2014-03-05 · Philips Medical Systems
  Reason: HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers
• HeartStart MRx Monitor/Defibrillator
  FDA Device · Class II · 2014-03-05 · Philips Medical Systems
  Reason: A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD), which can disrupt ECG and SpO2 functionality leading to an inability to perform.
• Philips HeartStart MRx Monitor/Defibrillator
  FDA Device · Class II · 2014-03-05 · Philips Medical Systems
  Reason: ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal
• HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricul…
  FDA Device · Class II · 2014-03-05 · Philips Medical Systems
  Reason: Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy source
• Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use i…
  FDA Device · Class II · 2014-03-05 · Philips Medical Systems
  Reason: Philips HeartStart XL may experience a power board failure causing failure to defibrillate
• Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medica…
  FDA Device · Class II · 2014-03-05 · Philips Medical Systems
  Reason: HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the specified 3 hour duration as stated in the labeling
• M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia and…
  FDA Device · Class II · 2014-03-05 · Philips Medical Systems
  Reason: Wireless Link may be unable to transmit data when configured for a specific data flow.
• Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in w…
  FDA Device · Class II · 2014-01-08 · Philips Medical Systems
  Reason: X-ray system C-arm casting may loosen and fall
• Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx is for…
  FDA Device · Class II · 2014-01-08 · Philips Medical Systems
  Reason: Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators. The first energy setting is labeled 10 when it should be labeled1-10
• Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx…
  FDA Device · Class II · 2014-01-08 · Philips Medical Systems
  Reason: Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and
• Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular ta…
  FDA Device · Class II · 2014-01-01 · Philips Medical Systems
  Reason: MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg
• Easy Diagnost Eleva Universal Fluoroscopic applications
  FDA Device · Class II · 2013-12-11 · Philips Medical Systems
  Reason: The delivered application software was an outdated version to the model of equipment.