Other Medical Devices

Sterility of device is compromised due to a sterile barrier breach

If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.

This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.

The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.

Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.

A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of unintended energy to the patient.

The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.

Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, additional medical intervention, or a revision surgery.

The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.

Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.

The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.