Ge healthcare (gehc) reported a field modification for this battery issue per 21 cfr 806 on 21-apr-2022.The fda recall number is z-1285-2022, z-1286-2022.Customers were sent a letter explaining the issue and requesting the customer to perform the battery performance test to determine if their batteries may be impacted.Gehc will provide battery replacements, updated user manual for battery capacity testing, battery preventative replacement frequency, and potentially new software based on the product model.No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.
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