Other Medical Devices

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

Laryngoscope handles may not illuminate as intended.

Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.

An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).

Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

Laryngoscope handles may not illuminate as intended.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.

Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.