Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe.
FDA Recall Z-1181-2021 · Posted None
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Recalling FirmGetinge Group Logistics America, LLC
Recall StatusTerminated
Product CodeBSZ
Date Initiated2021-01-29
Date Terminated2023-09-28
Product Quantity144 units
Reason for Recall
Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zero as expected and/or experienced System Check Out failures when docking the absorber to the Flow i Anesthesia machine.
Firm Action
On 2/9/2021 Maquet Critical Care AB / Getinge issued an Urgent Medical Device Correction letter via FedEx for the Flow i anesthesia machine due to the potential for high FiCO2 values and/or a System Check Out failure due to an incomplete docking of the CO2 absorber to the patient cassette. The patients re-breathing without CO2 reduction could occur if the absorber is not sufficiently docked.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, MA, MI, MO, NJ, NY, OH, OR, PA, TX, VA, WA, WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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