Reason: Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.
Distributed: US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.Reason: The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn.
Distributed: US Nationwide distribution in the states of WI, TN, TX, MD, GA, UT, WA, MI, NC, NE, CA, MA, CO, SC, OH, IN, MN, NM, PA, NY, IL, FL, NJ, VA, AZ, VT, CT, OK.Reason: Potential for anesthesia leakage.
Distributed: Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Kentucky, Maryland, Mississippi, Missouri, New Jersey, Puerto Rico, Texas, Washington, West Virginia and the country of Canada.Reason: Potential for anesthesia leakage.
Distributed: Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Kentucky, Maryland, Mississippi, Missouri, New Jersey, Puerto Rico, Texas, Washington, West Virginia and the country of Canada.Reason: The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model.
Distributed: Domestic: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MD, MN, MO, NM, NY, OH, OK, PA, RI, TX, UT, VA, WA, WI, WV, WY; International: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Iraq, Italy, Japan, Netherlands, Norway, Philippines, Poland, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Vietnam;Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Distributed: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Distributed: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Distributed: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Distributed: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Distributed: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.