Medical Devices Recalls

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity.

Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.

The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature.

The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Inadequate biocompatibility testing.

Potential for separation of the proximal handle from the shaft.

There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.

Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim persons (overestimation of systolic blood pressure, underestimation of diastolic blood pressure).

Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cause overheating and subsequent failing of the R56 thermistor of the power supply board. Board failure typically occurs when the compressor is switched on (prior to patient use); however, it can occur during patient use. This can shut down the compressor or the entire HCU 30 Type 2 unit.

Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,

Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner with a tilted gantry. In a 2x2 layout, the 4D tabcard will show an incorrect, too small length measurement. This could result in selecting a device of the wrong size, which then needs to be exchanged.

Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does not correctly represent the annotated Color Bar or Velocity Markers. (e.g.) When the Color Bar conveys that Red is to be displayed for color flow toward the Transducer, the system displays Blue for color flow toward the Transducer. This could result in misdiagnosis in some studies.