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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
Complaints of unexpected detachment of the collimator have been reported.
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.
It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
Event Catalog information does not save when copied and transferred from one unit to another.
Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.
Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids, by correction. The reason for the recall is: Beckman Coulter has determined that the DxI 9000 Access Immunoassay analyzer accepts calibrator values scanned from multiple calibrator cards when an operator configures a new calibrator lot. The analyzer accepts the calibrator lot values from any scanned calibrator card, regardless of the assay test code or calibrator material lot number. The software is not validating the integrity of each calibrator barcode scanned to ensure they are all from the same calibrator card. This includes all software versions and all DxI 9000 instruments that are currently in the field. This issue does not impact calibrator material with 2D calibrator card barcodes. This may cause a failed calibration curve. The health risk to patients is dependent upon the analytes that could be impacted by the error, to include receiving delayed or erroneous results. The issue was identified by Beckman Coulter while conducting a field action on DxI 9000 Access Immunoassay Analyzers.
Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.