All Recalls

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.

Fetal transducers distributed in advance of receiving 510(k) and international clearances.

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

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.

Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions.

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

Incomplete seals on the sterile package may compromise the sterility

Incomplete seals on the sterile package may compromise the sterility

Incomplete seals on the sterile package may compromise the sterility

Incomplete seals on the sterile package may compromise the sterility

Fetal transducers distributed in advance of receiving 510(k) and international clearances.

Incomplete seals on the sterile package may compromise the sterility

Incomplete seals on the sterile package may compromise the sterility

Incomplete seals on the sterile package may compromise the sterility

Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.

Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays were valid in the calibration menu whereas in fact the calibrations were expired and no alarm displayed to warn the users about the expiration date of the calibrations. Software computes results of analysis for assays with expired calibrations. The anomaly is due to an incorrect update of the calibration status by the software.

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