Reason: Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
Distributed: US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.Reason: It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used.
Distributed: U.S.Reason: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Distributed: US: Nationwide OUS: United Arab Emirates Australia Belgium Bahrain Botswana Canada Switzerland China France United Kingdom Gibraltar Israel India Kuwait Mexico Malaysia Netherlands New Zealand Philippines Pakistan Qatar Saudi Arabia Singapore Taiwan, Province of China South AfricaReason: The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
Distributed: Domestic: TN;Reason: Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).
Distributed: Domestic: TNReason: Potential that the measured value may be smaller than the actual area.
Distributed: US Nationwide distribution.Reason: Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.
Distributed: US Nationwide distribution in the states of MT, WI, IL.Reason: Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
Distributed: International distribution in the countries of Albania, Armenia, Australia, Austria, Belgium, Bosnia, Bulgaria, China, Croatia, Cyprus, Czech Republic/Slovakia, France, Germany, Greece, Iberia, India, Israel, Italy, Japan, Lithuania, Macedonia, Malaysia/Brunei, Moldova, Netherlands, Pakistan, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Switzerland, Taiwan, Thailand, and Turkey.Reason: The kits contain certain lots of cannula products where the catheter may not retain its shape.
Distributed: US Nationwide distribution in the state of CA.Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Distributed: Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.