All Recalls

Lipemic interference failed to meet the performance specification listed within the IFU.

There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

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, kinks/abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The firm's HHE also identified hardware issues related to these alarms.

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

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.

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.

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

There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances

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

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

Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.

Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product

The main injector fuel return hose can leak, posing a fire hazard. This can also result in serious property damage, injuries or even death.

Plastic control knobs with a black shaft on the cooktop can crack or break during use, posing a risk of gas leak, fire hazard.

The handlebar hooks on the recalled snowmobiles pose a puncture hazard and risk of serious injury if the rider's body impacts the handlebar hook during a crash.