All recalls8,506 total
Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
potential for metal in product
potential for metal in product
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn.
The device was incorrectly packed in the wrong size labeled outer packaging.
Mislabeled: Product may contain undeclared sesame seeds
Undeclared pine nut
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
Potential foreign object contamination
Potential foreign object contamination
Potential foreign object contamination
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
contains undeclared wheat
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
Product is missing the ingredient list (which lead to missing wheat and Yellow No. 6), and a nutritional panel.
Product contains undeclared cyclamates.
Product contains undeclared cyclamates.
The firm initiated a voluntary recall after NSF testing showed that labeled ingredient quantities did not align with analytical test results, manganese level was below label quantity.