Medical device recalls

Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.

Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.

During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient.

During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient.

During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient.

During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient.

During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient.

During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient.

During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.

A limited amount of Carina mobile lifts have been delivered with a too small locking pin. If a locking pin smaller than the correct size is mounted on the Carina mobile lift, the locking pin is likely to cause increased wear on the plastic bushings. In case of continued use, these components may cause wear on the metal of the piston rod eye.

During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts manufactured between April 25, 2017 and June 12, 2017 may wear prematurely at max load (625 lbs). We have identified the root cause as a supplied component that was not to specification. If the strap wears during use there is a potential risk for the person being supported by the lift to drop.

There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument.

The device may exhibit premature battery depletion.

The device may exhibit premature battery depletion.

The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.

The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.

Potential for intermittent lighting (flickering) during use.

Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the control range. (4.92  5.85 kPa or 36.9  46.9 mmHg) " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)

The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.

There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base.

There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base.

The high control for the kit is recovering low and may be out of range for assigned values.

The device had an incorrect printed calibration value on the calibration certificate.

The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.

The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.

The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.

There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.

There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac ResynchronizationTherapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.

There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.

There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.