All recalls7,869 total
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
Product label does not list ingredients including major food allergen: sesame. Additional undeclared ingredients include: millet and flax
Products may be contaminated with Listeria monocytogenes
Product was manufactured and held under insanitary conditions. Product may be contaminated with Listeria monocytogenes.
Product label does not list ingredients including major food allergen: sesame. Additional undeclared ingredients include: poppy seeds, dried garlic, dried onion, and sea salt
Potential contamination with foreign objects.
Products may be contaminated with Listeria monocytogenes
Product label does not list ingredients including major food allergens: wheat and soy (vegetable oil). Additional undeclared ingredients include: niacin, reduced iron, vitamin B1, vitamin B2, invert sugar
Products may be contaminated with Listeria monocytogenes
Products may be contaminated with Listeria monocytogenes
Limited system movements after startup .
Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Their is the potential for weak staining which may result in false negative CD20 identification.
Product may be contaminated with Listeria monocytogenes
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Their is the potential for weak staining which may result in false negative CD20 identification.
Their is the potential for weak staining which may result in false negative CD20 identification.
Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client ( Pressure Sensor Defective ) during non-invasive blood pressure (NIBP) measurements, specifically when the initial inflation pressure is set in the high-pressure range (>240 mmHg). The ARGUS PB-3000 is a vital signs monitoring instrument intended to be integrated into the Merge Hemo System. No other components of the Merge Hemo System are affected.
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Software issue that results in the display of outdated information.
Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.
Convenience kits labeled as sterile have not gone through the sterilization process.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.