September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Airway Mobilescope, Models MAF-GM & MAF-TM.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Model BF-Q180-AC
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Accuray Incorporated recalls Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
Hazard: It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel.
September 6, 2023Medical DevicesFDA
Beckman Coulter Inc. recalls Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
Hazard: Lipemic interference failed to meet the performance specification listed within the IFU.
September 6, 2023Medical DevicesFDA
Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Hazard: Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
September 6, 2023Medical DevicesFDA
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099
Hazard: Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
September 6, 2023Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Hazard: Loss of availability of the wireless foot switch during procedures.
September 6, 2023Medical DevicesFDA
Oculus Optikgeraete GMBH recalls Oculus Myopia Master , Ref 68100, CE 0123
Hazard: Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
September 6, 2023Medical DevicesFDA
Oculus Optikgeraete GMBH recalls Oculus Pentacam AXL , Ref 70100, CE 0123
Hazard: Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
September 6, 2023Medical DevicesFDA
Oculus Optikgeraete GMBH recalls Oculus Pentacam AXL Wave, Ref 70020, CE 0123
Hazard: Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
September 6, 2023Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis impla
Hazard: A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Visera Hysterovideoscope Olympus HYF Type V
Hazard: IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
September 6, 2023Medical DevicesFDA
Edwards Lifesciences, LLC recalls PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Hazard: Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rotation or additional implant implantation.
September 6, 2023Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Hazard: There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
September 6, 2023Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Hazard: There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
September 6, 2023Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Hazard: There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
September 6, 2023Medical DevicesFDA
Alphatec Spine, Inc. recalls LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, T
Hazard: Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.
September 6, 2023Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human se
Hazard: Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)
September 6, 2023Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl tran
Hazard: Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica¿ CH HDL Cholesterol (HDLC)
September 6, 2023Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human seru
Hazard: Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica¿ CH HDL Cholesterol (HDLC)
September 6, 2023Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human se
Hazard: Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirubin_2 (TBil_2), Atellica¿CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica¿CH HDL Cholesterol (HDLC)
September 6, 2023Medical DevicesFDA
Skytron, LLC recalls GS70H Salus Surgical Table, Product Code 18-071-70
Hazard: When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and the surgical table. However, during investigation, Mizuho discovered that the failure could be replicated even in wired mode if communication between the pendant and table were somehow interrupted. The root cause appears to be: if communication between the controller and table is interrupted while a button is pressed, the table does not know if/when a button is released. This occurs in wireless or wired mode.
September 6, 2023Medical DevicesFDA
Skytron, LLC recalls GS70 Salus Surgical Table, Product Code 18-070-70
Hazard: When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and the surgical table. However, during investigation, Mizuho discovered that the failure could be replicated even in wired mode if communication between the pendant and table were somehow interrupted. The root cause appears to be: if communication between the controller and table is interrupted while a button is pressed, the table does not know if/when a button is released. This occurs in wireless or wired mode.
September 6, 2023Medical DevicesFDA
LeMaitre Vascular, Inc. recalls The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ
Hazard: Burrs (molding flash) on the cutter may tear the harvested vien
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Hazard: Recent reports of patient infection.
September 6, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Hazard: Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product