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.
Recall
- Recall Number
- Z-1181-2021
- Event Number
- 87301
- Firm
- Getinge Group Logistics America, LLC
- FEI Number
- 3025504317
- Product Code
- BSZ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- January 29, 2021
- Terminated
- September 28, 2023
- Address
- 45 Barbour Pond Dr, Wayne, NJ, 07470-2094
Description
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.
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.
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.
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.
144 units