Product: SPECTRA OPTIA AFERESE SYSTEM. Model: AFERESE SPECTRA OPTIA SYSTEM. Anvisa Registration n ° 80554210002. 의 안전성 경고

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.

According to the company, this possible error does not present risk to the functionality of the equipment. The error may occur in the following circumstances: (1) The user accidentally changes the weight and height values ​​when entering data into the Spectra Optia System; (2) The patient is weighed and measured in units that are different from those selected by the user in the equipment; (3) The user includes inaccurate height and weight data; (4) Abnormal calculation of the patient's total blood volume that may affect the outcome of the procedure.