The "SFDA" Issued a Field Safety Notice Regarding Use of "Non-Contact Forehead - Infrared Thermometer IM-9001"
2020-07-08
The Saudi Food and Drug Authority (SFDA) has issued a field safety corrective action about "non- contact forehead - Infrared Thermometer IM-9001" due to inaccurate temperature measurements.
The device is manufactured by the Shenzhen Anbson Industries Co. Ltd.
Origin: China
The SFDA has taken the necessary actions to follow up on the recalled device from the Saudi markets, ban their entry, and take the formal steps against non-compliance.
Therefore, SFDA recommends consumers stop using this device, return it, and get a refund.
In case if the seller refuses to refund, please contact the Consumer Complaints Center (1900) for the Ministry of Commerce.
Consumers can report any incidents/adverse events or problems suspected to be relevant to the medical devices to SFDA call center 19999, or the National Center for Medical Devices Reporting or the Saudi Vigilance Center.