Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
Zero-Gravity Radiation Protection System (overhead suspended radiation protection shield)Zero-Gravity ceiling mounted monorail with hinged swing armCatalogue Number: 412766TIDI Part Number: ZGCM-HSASerial Number: 582023Zero-Gravity floor unitCatalogue Number: 403803TIDI Part Number: ZGM-6.5HSerial Number: 549772Supplied and installed between 28 June 2010 and 31 August 2016ARTG Number: 221225