All Recalls

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

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.

Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

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.

IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.

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

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)

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.

Users were identifying autofill failure conditions on the devices causing pump stops.

Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Recent reports of patient infection.

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.