Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
Distributed: Worldwide Distribution - USA (nationwide) and the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and CanadaReason: System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.
Distributed: Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.Reason: GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side by side by selecting "Compare Study" from the Study List, or by opening prior studies in the Patient Folder. In these cases, the Viewer differentiates the studies wityh a label (Curr
Distributed: USA Nationwide Distribution in the state of OKReason: There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system.
Distributed: Worldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy.Reason: The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0.
Distributed: US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WAReason: Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. This included recommending the use of Sterile Cover JG901 and new Quick Release Coupling RT02OR to eliminate the need to sterilize the UNITRAC and a functional check was added prior to use to ensure optimal functionality of the UNITRAC system.
Distributed: Nationwide Distribution.Reason: Some devices may be contaminated on the back side of the device with glue in the blood application area.
Distributed: US distribution in OHReason: OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures.
Distributed: Worldwide distribution: US (nationwide) including states of: CA, MA, MN, and VA; and countries of: China, Guatemala, India, Iraq, South Korea, and Untied Arab Emirates.Reason: An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result.
Distributed: USA Nationwide Disatribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, MA, ME, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WIReason: FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.
Distributed: Worldwide Distribution - USA Nationwide in the states of Florida, Georgia, Oklahoma, Pennsylvania, Tennessee, Texas, West Virginia, and in the country Japan and Italy.