PHILIPS MEDICAL SYSTEMS Recalls

Hazard: 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.

Hazard: 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.

Hazard: 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 cause the battery to ignite or explode.

Hazard: 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.

Hazard: Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations

Hazard: A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy

Hazard: Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy.

Hazard: 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.

Hazard: 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

Hazard: 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

Hazard: ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal

Hazard: HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers

Hazard: Philips HeartStart XL may experience a power board failure causing failure to defibrillate

Hazard: Wireless Link may be unable to transmit data when configured for a specific data flow.

Hazard: 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

Hazard: 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.

Hazard: 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

Hazard: 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

Hazard: X-ray system C-arm casting may loosen and fall

Hazard: MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg

Hazard: The delivered application software was an outdated version to the model of equipment.