95,089 total recalls in our database
Siemens Healthcare Diagnostics
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
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.
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kins and abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The HHE also identified hardware issues related to these alarms.
Oculus Optikgeraete GMBH
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Siemens Healthcare Diagnostics
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Olympus Corporation of the Americas
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Olympus Corporation of the Americas
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Siemens Healthcare Diagnostics
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)
Siemens Healthcare Diagnostics
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)
Siemens Healthcare Diagnostics
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Olympus Corporation of the Americas
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Olympus Corporation of the Americas
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.
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.
Siemens Healthcare Diagnostics
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Olympus Corporation of the Americas
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Olympus Corporation of the Americas
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Olympus Corporation of the Americas
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Edwards Lifesciences
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.