Oculus Pentacam AXL , Ref 70100, CE 0123
Oculus Optikgeraete GMBH
Class I - Dangerous
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium heparin, potassium EDTA) using the Atellica CH Analyzer SMN: 11097591
Siemens Healthcare Diagnostics
Class I - Dangerous
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Olympus Bronchovideoscope, Models BF-3C160.
Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597
Siemens Healthcare Diagnostics
Class I - Dangerous
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)
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213
Siemens Healthcare Diagnostics
Class I - Dangerous
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)
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632
Siemens Healthcare Diagnostics
Class I - Dangerous
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
Class I - Dangerous
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.
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604
Siemens Healthcare Diagnostics
Class I - Dangerous
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.
Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Edwards Lifesciences
Class I - Dangerous
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.
Visera Hysterovideoscope Olympus HYF Type V
Olympus Corporation of the Americas
Class I - Dangerous
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01
Waldemar Link GmbH & Co. KG (Mfg Site)
Class I - Dangerous
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
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531
Siemens Healthcare Diagnostics
Class I - Dangerous
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)
Class I - Dangerous
Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.