Ge healthcare reported a field modification for this ic9-rs double image malfunction per 21 cfr 806 on 29-dec-2023.The us-fda recall number is z-0865-2024.Customers were sent a letter explaining the issue and requesting the customer to perform an inspection test to determine if the probe is malfunctioning.Ge healthcare has determined the cause of the malfunctioning probe to be a probe component.Ge healthcare will replace the probe upon completion of the field action at this site.Legal manufacturer: hcs kretz - tiefenbach 15 austria zipf oberosterreich, 4871.
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