Anesthesia gas-machine - Product Usage: intended for use in… recallZ-1181-2021 · Getinge Group Logistics America, LLC · initiated Jan 29, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Getinge Group Logistics America, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1181-2021
- Status
- Terminated
- Initiated by the company
- Jan 29, 2021
- Recalling firm
- Getinge Group Logistics America, LLC
- Quantity
- 144 units
- Product code
- BSZ
- FDA submissions
- K191027
- 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.
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.
Code information (models, lots, serial numbers)
UDI Code: Flow i C20 Anesthesia System 6677200 07325710001349, Flow i C30 Anesthesia System 6677300 07325710001349, Flow i C40 Anesthesia System 6677400 07325710001318, Flow c Anesthesia System 6887700 07325710009765 Serial Number: 1172, 1546, 2095, 2719 2724, 5427 5429, 6132, 6819, 1202, 1643 1657, 2186, 2729 2733, 5540 5542, 6133, 6820, 1204,1786, 2553 2555, 2735 2747, 5589, 6525, 6821, 1224 1226, 1787, 2557 2562, 2851 2856, 5590, 6562, 6822, 1277, 1860, 2613, 2858 2869, 5812 5814, 6736, 6823, 1280 1282, 1861, 2714, 4548 4550, 5895 6737, 6824, 1545, 2021 2024, 2716, 5198 5203, 6077, 6818, 6940, 1058, 1059, 1060, 1167, 1169, 1201, 2034, 5204 5211, 7185, 4003.
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Flow-c Anesthesia System 6887700Maquet Critical Care AB · Gas-Machine, Anesthesia6 recalls72 reports
- FLOW-i C20 6677200Maquet Critical Care AB · Gas-Machine, Anesthesia4 recalls99 reports
- FLOW-i C40 6677400Maquet Critical Care AB · Gas-Machine, Anesthesia4 recalls5 reports
Other devices under the same FDA submission
5 devices cleared under K191027 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Flow-e Anesthesia System 6887900Maquet Critical Care AB · Gas-Machine, Anesthesia5 recalls19 reports
- Flow-i C20 Anesthesia System 6888520Maquet Critical Care AB · Gas-Machine, Anesthesia1 recall2 deaths88 reports
- Flow-i C30 Anesthesia System 6888530Maquet Critical Care AB · Gas-Machine, Anesthesia1 recall13 reports
- Flow-i C40 Anesthesia System 6888540Maquet Critical Care AB · Gas-Machine, Anesthesia1 recall9 reports
- Vaporizer Sevoflurane, MAQUET filling 6886601Maquet Critical Care AB · Gas-Machine, Anesthesia1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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