Medical Devices Recalls

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

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.

Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.

Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.