January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6A
Hazard: Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / Q
Hazard: Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
January 17, 2024Medical DevicesFDA
BioFire Diagnostics, LLC recalls The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE
Hazard: A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.
January 17, 2024Medical DevicesFDA
BioFire Diagnostics, LLC recalls BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test i
Hazard: A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.
January 17, 2024Medical DevicesFDA
Immunostics, Inc. recalls Detector H. Pylori, Catalog Number IHP-30
Hazard: Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause false positive, false negative, or invalid results.
January 17, 2024Medical DevicesFDA
Icotec Ag recalls VADER pedicle system, torque wrench, Catalog Number 42-703
Hazard: icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.
January 17, 2024Medical DevicesFDA
Icotec Ag recalls VADER pedicle system, torque wrench, Catalog Number 42-702
Hazard: icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.
January 17, 2024Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
Hazard: Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
January 17, 2024Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Hazard: Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
January 17, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light sou
Hazard: Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.
January 17, 2024Medical DevicesFDA
Medtronic Xomed, Inc. recalls NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c
Hazard: Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
January 17, 2024Medical DevicesFDA
SoClean, Inc recalls SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
Hazard: New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClean device.
January 17, 2024Medical DevicesFDA
SoClean, Inc recalls SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Hazard: New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClean device.
January 17, 2024Medical DevicesFDA
Shirakawa Olympus Co., Ltd. recalls Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
Hazard: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
January 17, 2024Medical DevicesFDA
Shirakawa Olympus Co., Ltd. recalls Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
Hazard: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
January 17, 2024Medical DevicesFDA
Shirakawa Olympus Co., Ltd. recalls Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
Hazard: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
January 17, 2024Medical DevicesFDA
Shirakawa Olympus Co., Ltd. recalls Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
Hazard: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
January 17, 2024Medical DevicesFDA
Shirakawa Olympus Co., Ltd. recalls Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE
Hazard: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
January 17, 2024Medical DevicesFDA
Shirakawa Olympus Co., Ltd. recalls Model No. BF-XP190, EVIS EXERA III Bronchovideoscope
Hazard: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
January 17, 2024Medical DevicesFDA
Shirakawa Olympus Co., Ltd. recalls Model No. BF-P190, EVIS EXERA III Bronchovideoscope
Hazard: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
January 17, 2024Medical DevicesFDA
Shirakawa Olympus Co., Ltd. recalls Model No. CYF-5R, Cystonephrofiberscope
Hazard: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
January 17, 2024Medical DevicesFDA
Shirakawa Olympus Co., Ltd. recalls Model No. CYF-5, Cystonephrofiberscope
Hazard: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
January 17, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Sensis Vibe Hemo
Hazard: The possibility of the Sensis documentation functionality application to crash.
January 17, 2024Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000
Hazard: The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
January 17, 2024Medical DevicesFDA
Abbott Laboratories recalls Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer al
Hazard: The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
January 17, 2024Medical DevicesFDA
Abbott Laboratories recalls Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer
Hazard: The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
January 17, 2024Medical DevicesFDA
Philips North America recalls BrightView XCT, Gamma Camera, Product Code 882482
Hazard: While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
January 17, 2024Medical DevicesFDA
Philips North America recalls BrightView X, Gamma Camera, Product Code 882478
Hazard: While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
January 17, 2024Medical DevicesFDA
Philips North America recalls BrightView, Gamma Camera System, Product Code 882480.
Hazard: While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
January 17, 2024Medical DevicesFDA
Bard Peripheral Vascular Inc recalls BD Recanalization System, REF: BDRECANSYSTEM
Hazard: Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.