Official product recall notices and clearly labeled enforcement reference records.
Reference notice · device
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Bedford, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Bedford, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.
Marlborough, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound.
East Hampton, CT, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Mahwah, NJ, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Mahwah, NJ, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Mahwah, NJ, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Mahwah, NJ, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
Tustin, CA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Mahwah, NJ, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire safety risk.
Kitchener, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
Burlington, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Mahwah, NJ, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of blood and exposure of the operator or surrounding work area to a biological hazard (…
Cortlandt Manor, NY, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Mahwah, NJ, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Mahwah, NJ, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.
Mentor, OH, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.
Irvine, CA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not…
Mentor, OH, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not…
Mentor, OH, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and infection.
Huntersville, NC, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not…
Mentor, OH, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configura…
Brea, CA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not…
Mentor, OH, US · Event · Updated
Source: FDA — device enforcement referenceReport a correction · Related news · Fire information · Clips
