Heartstart XL M4735A Defibrillator - Registered at ANVISA under the number 10216710063. Serial numbers affected: see http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/980_produtos_afetado.pdf. 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.

The equipment serial numbers that are identified in the Distribution List provided by Philips are affected by this problem. To identify an affected unit, locate the serial number on the bottom of the HeartStart XL. Philips has already initiated corrective action (FSN86100076) of the affected equipment and considers this correction necessary for them. The company is contacting users who have equipment listed in the Distribution List of affected units to schedule replacement of the power selection button. If additional information or support is required regarding this issue, please contact the Philips Medical System Solution Center at 0800-701-7789 (Monday to Friday from 7:30 a.m. to 7:00 p.m. and 8 a.m. to 3 p.m. on Saturdays). When contacting the company, have the corrective action code initiated by the company (FSN86100076) available to facilitate communication. Anvisa's Technovigilance Unit is monitoring this case.