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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Products were stored outside of labeled temperature requirements.
Products were stored outside of labeled temperature requirements.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the transport handle during transport, resulting in a mild static electric shock.
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
Products were stored outside of labeled temperature requirements.
Products were stored outside of labeled temperature requirements.
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
Due to product outer packaging incorrectly labeled.
There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload within the generator. Should an event like this occur, the system will become inoperable and loud noise, burnt smell and smoke may be detectable.
Unexpected failure of electrical components within the CPI generator.
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coating solution resulting in precipitation during coating runs. The device defect can cause false negative results that may lead to a delay in treatment of patients with associated conditions such as diabetic ketoacidosis.
Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.