March 13, 2024Medical DevicesFDA
Invacare Corporation recalls Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54
Hazard: Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components
March 13, 2024Medical DevicesFDA
Canon Medical System, USA, INC. recalls Vantage Titan, Model: MRT-1504
Hazard: For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
March 13, 2024Medical DevicesFDA
Canon Medical System, USA, INC. recalls MRI system: Vantage Elan, Model: MRT-2020
Hazard: For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
March 13, 2024Medical DevicesFDA
Canon Medical System, USA, INC. recalls MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
Hazard: For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
March 13, 2024Medical DevicesFDA
Aesculap Inc recalls DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.
Hazard: The sterile blister packaging may be damaged, and sterility may be compromised.
March 13, 2024Medical DevicesFDA
Aesculap Inc recalls DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
Hazard: The sterile blister packaging may be damaged, and sterility may be compromised.
March 13, 2024Medical DevicesFDA
Aesculap Inc recalls DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
Hazard: The sterile blister packaging may be damaged, and sterility may be compromised.
March 13, 2024Medical DevicesFDA
Aesculap Inc recalls DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.
Hazard: The sterile blister packaging may be damaged, and sterility may be compromised.
March 13, 2024Medical DevicesFDA
Aesculap Inc recalls DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
Hazard: The sterile blister packaging may be damaged, and sterility may be compromised.
March 13, 2024Medical DevicesFDA
Synthes (USA) Products LLC recalls Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231
Hazard: Products not sterilized, sterility cannot be confirmed
March 13, 2024Medical DevicesFDA
Synthes (USA) Products LLC recalls VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
Hazard: Products not sterilized, sterility cannot be confirmed
March 13, 2024Medical DevicesFDA
Synthes (USA) Products LLC recalls TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractu
Hazard: Products not sterilized, sterility cannot be confirmed
March 13, 2024Medical DevicesFDA
Synthes (USA) Products LLC recalls TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractur
Hazard: Products not sterilized, sterility cannot be confirmed
March 13, 2024Medical DevicesFDA
Synthes (USA) Products LLC recalls RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures o
Hazard: Products not sterilized, sterility cannot be confirmed
March 13, 2024Medical DevicesFDA
Synthes (USA) Products LLC recalls RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear th
Hazard: Products not sterilized, sterility cannot be confirmed
March 13, 2024Medical DevicesFDA
Synthes (USA) Products LLC recalls 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.
Hazard: Products not sterilized, sterility cannot be confirmed
March 13, 2024Medical DevicesFDA
Synthes (USA) Products LLC recalls 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
Hazard: Products not sterilized, sterility cannot be confirmed
March 13, 2024Medical DevicesFDA
Synthes (USA) Products LLC recalls 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis
Hazard: Products not sterilized, sterility cannot be confirmed
March 13, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 7600 Integrated System, Catalog No. 6844461
Hazard: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
March 13, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 3400 Chemistry System, Catalog No. 6844458
Hazard: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
March 13, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Hazard: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
March 13, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Hazard: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
March 13, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Hazard: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
March 13, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 7600 Integrated System, Catalog No. 6844461
Hazard: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
March 13, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 3400 Chemistry System, Catalog No. 6844458
Hazard: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
March 13, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Hazard: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
March 13, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Hazard: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
March 13, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Hazard: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
March 13, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
Hazard: Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and potential data loss.
March 13, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS XT7600 Integrated System
Hazard: Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.