Safety Alert for Acuson Sequoia C512 / C256 / 512 # Series Affected Series Acuson Sequoia C512 / C256 / 512 # Product Name: Acuson Sequoia C512 / C256 / 512 # Product Name: ACUSON SEQUOIA ULTRASONIC SYSTEM # : 40507963, 41008034, 41008038, 41608093

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Recommendations to users: "To avoid the potential risk of this problem, Siemens recommends: - Perform the leak test for the transesophageal transducer before each use (this test may indicate cracks, cuts, tears, perforations and protuberances in the joint material , and thus avoid possible risk to the patient and / or operator) - Use only Siemens approved cleaning and disinfection solutions - Carefully follow manufacturer's instructions - Use commercially available transducer guides designed specifically for TEE applications. Follow the instructions provided by the manufacturer of the transducer guide - When storing the transesophageal transducer, take extreme care to keep the transducer tip vertically - Never move the transducer end by hand Always use the flexible controls Recommended steps are provided in the existing user's manual of the ultrasound system. s have been instructed to share the information contained in the letter with all employees in your organization who need to know about this problem and to file the letter with the Operator's Manual. "