Overview of recall records associated with Philips North America, LLC, including dates, categories and classifications where available.
Classification mix: Class II: 369, Class I: 4, Class III: 2.
The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function;…
The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the…
Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations
Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices.
The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements.
The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.
The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of…
Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX…
Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX…
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
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.
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.
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.
This page summarizes recall records in which the official source identifies Philips North America, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
