Other Medical Devices

Ultrasound transducer devices were refurbished beyond their useful life.

Cather packaging may contain the incorrect French size.

Ultrasound transducer devices were refurbished beyond their useful life.

A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

Ultrasound transducer devices were refurbished beyond their useful life.

Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.

There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.

Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.

There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.

Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.

The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.

Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.

There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.

Lack of sterility assurance.