Overview
- ANMAT published a nationwide ban on the Cabezal 810nm 2cm Speed de Soprano ICE (S/N ICE122001380), class III medical device, prohibiting its use, sale and distribution because its location and condition could not be verified.
- The probe began when Sirex Médica S.A., the registered importer for ALMA LASERS, found the serial number missing from its records and the manufacturer confirmed the unit was originally sold for the United States, which led ANMAT to question how it entered Argentina.
- ANMAT notified provincial health authorities and the National Institute of Medical Products and asked its Coordination of Judicial Affairs to pursue legal action after inspectors failed to locate the device and could not confirm safe handling.
- In a separate disposition, ANMAT barred Body Aling SRL from distributing medical products across provinces until it obtains national habilitation, opened a sanitary sumario for possible unauthorized interjurisdictional sales, and reported inspectors were not admitted at the firm’s Villa Tesei addresses.
- Class III devices face stricter controls because they can harm patients or operators, so the agency’s move aims to protect public health and could lead to administrative sanctions, appeals within the published timeframes or further judicial steps while tracing of the supply chain continues.