Reason: A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Distributed: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, United Kingdom.Reason: A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Distributed: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, United Kingdom.Reason: The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
Distributed: Worldwide - US Nationwide distribution in the states of CO, CT, KY, NJ, TN, TX, UT and the countries of Belgium, Singapore, Taiwan, Germany, Switzerland.Reason: Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
Distributed: Worldwide distribution - US Nationwide and the countries of GU, and MP.Reason: Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
Distributed: Worldwide distribution - US Nationwide and the countries of GU, and MP.Reason: Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.
Distributed: US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country of Canada.Reason: The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
Distributed: Domestic: US Nationwide Distribution. International: Australia, Belgium, Canada, Chile, China Mainland, Czech Republic, Denmark, Ecuador, Finland, France, Germany, GHANA, Hungary, India, Italy, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Thailand, T¿rkiye, United Kingdom, Utd.Arab Emir., Vietnam,Reason: The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
Distributed: US Nationwide distribution.Reason: Polyaxial screws do not meet performance standards.
Distributed: US Nationwide distribution in the states of California, North Carolina, and Texas.Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Distributed: US Nationwide distribution.