Diagnostic Equipment

There is a potential for internal leaks within catheters.

Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which could lead to the emission of wear / corrosion particles in the operated area, potentially leading to the following risks: Inflammation, pain, allergy, adverse tissue reaction. Device description: The drill bit is used to create the hole required for the introduction of the screw, it is suitable for Neosteo compression screws for cortical and spongy bone. Drilling depth can be read on the instrument. The shaft is coupled with the ¿4.5mm surgical motor using a AO ¿4.5mm male drive connexion. The countersink bit is coupled to a ¿1.0mm k-wire to ensure guiding while drilling. The instrument is packaged in a plastic sheath sealed by welding.

Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.

There is a potential for internal leaks within catheters.

There is a potential for internal leaks within catheters.

There is a potential for internal leaks within catheters.

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality.

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.

Misaligned placement of an axis mark can cause the patient to experience blurred vision