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One client reported that HL7 files transferred to an outbound results interface (specific to one client) would sometimes contain more than one patient identifier, which could lead to results being assigned to the wrong patient in a third party system…

GE Healthcare has become aware of two potential issues where inaccurate distance and area measurements can be displayed. Recall start date: May 5, 2022

Surestrips Rapid Response Covid-19 Antigen Rapid Test Device are not authorized for sale in Canada as they were re-packaged into single tests and re-labelled without authorization by the manufacturers listed on the label (i.e.…

Surestrips Covid-19 Antigen Tests are not authorized for sale in Canada as they were re-packaged into single tests and re-labelled without authorization by the manufacturers listed on the label (i.e. Artron Laboratories Inc.).  Recall start date…

After initiating testing by a third-party lab, it was discovered that the tested lots did not meet the astm d6319 standard for medical gloves. Initial testing was received on March 4, 2022 and communicated to the original manufacturer. Confirmatory third…

Since Nov. 2020, Arjo has become aware of 2 customer complaints involving overheating of metal part of the device located underneath its frame. The part involved is referred to as the e-bay box. No adverse health consequences (including temporary or…

During continuous post market surveillance, Draeger gathered information and market feedback indicating that there is a need to provide additional information in the instructions for use regarding the potential of the user to incorrectly position the…

Customer complaint on over-inflation (abnormal inflation issue) occurring during the product installation, Preparation to initiate therapy or product use. In none of those events, any injury or health consequences were reported. the products in the…

An increase in complaints related to incomplete seals or the dressing been trapped in packaging was observed. As a potential hazard associated with these complaints involve the dressing being open or the product being sealed within the same primary…

Customer complaint on over-inflation (abnormal inflation issue) occurring during the product installation, preparation to initiate therapy or product use. In none of those events, any injury or health consequences were reported. The products in the…

The ook snow ALL when used with motorized wheel system, and bearing the option number OL2000200WG may continue to move forward even after the trigger was released. Recall start date: Apr 11, 2022

It has come to Xvivo knowledge that the sterile barrier (welded polybag) show defects in the weld for a number of batches of the Xvivo Organ Chamber. Defect was categorized as unsealed sections of the weld (compromised sterile barrier). To reinforce the…

Steris has identified that in the remote occurrence in which the electrical contactor component present in the drying chamber of the Reliance Synergy Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually…

Cardinal Health is initiating an urgent medical device correction to update the clinician and patient user manuals for the Negative Pressure Wound Therapy Sved Device to add pertinent information related to periodic preventative maintenance for this…

Avanos medical is conducting a voluntary field correction for the Cortrak* 2 Enteral Access System (Eas) because modifications to the labeling of the device have been initiated. Reports of injuries and patient deaths related to misplacement of…