Medical device recalls

Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than the original English version. The implants are standard length fracture stems.

Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach

On September 27, 2019 Energetiq Technology (the manufacturer) discovered a problem with their EQ-400-RH-QZ and EQ-400-LH-BK products during routine manufacturing functional testing. It was noted that a safety interlock within the lamp does not function in a reliable manner to shut down the system if the laser collimator is removed from the lamp while the system is operating. This is a potential safety hazard for anyone working on or nearby the lamp.

This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018.

This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018.

Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional intervention. Also, reports of clogging of phacoemulsion equipment tubing, which may lead to delay in the procedure or ocular injury.

Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue with Elekta regarding setting of guard leaves. iii)SSD, when intended as source-to-surface distance, it sometimes gives source-to-skin distance.To the best of our knowledge, these issues have not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect dose calculations during treatment planning.

There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.

The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.

A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience Kit contained LATEX.

On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the system will translate the decimal point separators to commas. This will result in invalid concentration values for the fluids, therefore the system will utilize default nominal values instead of lot specific IMT fluid concentration values for calculation of the calibrations and results for the Na, K, and Cl methods.

Microscopic tears of the sterile pouch may compromise sterility

Microscopic tears of the sterile pouch may compromise sterility

Microscopic tears of the sterile pouch may compromise sterility

Microscopic tears of the sterile pouch may compromise sterility

Microscopic tears of the sterile pouch may compromise sterility

Microscopic tears of the sterile pouch may compromise sterility

Microscopic tears of the sterile pouch may compromise sterility

Microscopic tears of the sterile pouch may compromise sterility

Microscopic tears of the sterile pouch may compromise sterility

Microscopic tears of the sterile pouch may compromise sterility

Microscopic tears of the sterile pouch may compromise sterility

Microscopic tears of the sterile pouch may compromise sterility

Microscopic tears of the sterile pouch may compromise sterility

Microscopic tears of the sterile pouch may compromise sterility

Microscopic tears of the sterile pouch may compromise sterility

Microscopic tears of the sterile pouch may compromise sterility

The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.

The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit

Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may result in erroneous Specific Gravity (SG) results.