All Recalls

Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and interruption of monitoring due to device failure that could lead to delay in detecting maternal or fetal distress.

Incomplete seals on the sterile package may compromise the sterility

Incomplete seals on the sterile package may compromise the sterility

Potential for leakage at the joint between the blood filters and tubing

Potential for leakage at the joint between the blood filters and tubing

Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.

Incomplete seals on the sterile package may compromise the sterility

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Incomplete seals on the sterile package may compromise the sterility

Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.

The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Incomplete seals on the sterile package may compromise the sterility

Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions

Incomplete seals on the sterile package may compromise the sterility

Incomplete seals on the sterile package may compromise the sterility

There is a potential for some systems built between 2014 and Jan 2018 to have a light output falling below the recommended minimum output. This problem has been associated with exposure of the light pipe to elevated temperatures, which is contra-indicated in the Operation, Maintenance, and Service Manual.