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.
Reported: March 17, 2021 Initiated: January 29, 2021 #Z-1181-2021
Product 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.
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.
Details
- Recalling Firm
- Getinge Group Logistics America, LLC
- Units Affected
- 144 units
- Distribution
- 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.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Getinge Group Logistics America, LLC. Units affected: 144 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 17, 2021. Severity: Moderate. Recall number: Z-1181-2021.
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