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.
Check against the official notice below — it lists the full affected range.
Getinge Group Logistics America, LLC is recalling 144 Maquet Critical Care AB Flow i Anesthesia machines distributed nationwide. The machines were intended to administer anesthesia while controlling patient ventilation. The recall was initiated because the devices experienced problems where the FiCO2 value (a measure of carbon dioxide) was not at or near zero as expected and/or the machines failed System Check Out procedures when the absorber was docked to the anesthesia machine.
The affected anesthesia systems include Flow i C20, C30, and C40 models, as well as Flow c systems, with specific UDI codes and serial numbers identified in the recall. The machines were distributed across multiple states including California, Florida, New York, Texas, Pennsylvania, and others. The source document does not specify a remedy or recommended action for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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. Quantity: 144 units Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.