BD Pyxis Pro MedStation Main, REF: 1155-00
CareFusion 303
Class I - Dangerous
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
ICU Medical
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Canon Medical System, USA
Class I - Dangerous
Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
PHILIPS MEDICAL SYSTEMS
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class I - Dangerous
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class I - Dangerous
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.