No report of patient involvement.This complaint is not serial # dependent but rather refers to all aisys cs2 mri product wherein the flow sensors have a manufacture date of 2021-06 or later.As this is not serial number specific, there is no specific udi number.Date of device manufacture: the date of device manufacture is prior to june 2021 as the fault was identified to have occurred in flow sensors manufactured prior to june 2021.Ge healthcare (gehc) reported a field modification for this issue per 21 cfr 806 on 28 july 2021 under report number 2126677-07/28/21-006-c.Customers were sent a letter explaining the issue and were provided the following safety instructions: always complete a pre-use checkout, including circuit leak test or breathing system tests, on your anesthesia machine prior to use.Follow instructions in the anesthesia machine user reference manual sections for preoperative checkout and preoperative tests쳌.Review all inventory of flow sensors, including those installed in anesthesia machines, in spare inventory, in reprocessing locations, and other locations not in use.Take care while handling flow sensors during removal, insertion, reprocessing, storing, or other types of handling, as damage could occur to the tubing and create cuts or punctures that affect flow sensor performance.
|