Diagnostic Equipment

The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a consequence of a lower electromagnetic shielding provided by the cable harness, the CO/CO2 sensor could have been influenced by high frequencies emitted by very close devices.

Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on to run a self-test. If this occurs, the device will indicate that it is not ready for use.

The incorrect outer carton box was used for the product.

The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.

Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips.

Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was made aware of this issue from customer complaints. Internal testing demonstrated that the amount of CO2 absorbed is higher with increased reagent carousel rotation and when the volume of reagent in the cartridge is reduced. This phenomenon can be detected as a shift in QC. The shift is predictive in both direction and magnitude of the potential impact to patient results.

The indicator may show available charge when the battery is close to depletion. As a result, the Site~Rite 8 has the potential to abruptly shut down, without advance warning to the user, when running on battery power only

Identified potential false positive MSI-H on the test reports provided to the physicians.

Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particulate matter or microbial growth.

Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth.

The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy level different from the setting selected by the user.

Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.

Unintentional shifting of the tip insulation of the firm's electrosurgical probes.

As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes

As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could result in blood exposure or erroneous results due to an inappropriate blood-to-additive ratio.

Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance.

Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.