Getinge Group Logistics America, LLC Recall 87301
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.
Getinge Group Logistics America, LLC Recall 87301 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1181-2021 |
| Event ID | 87301 |
| Event 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. |
| Product Type | Devices |
| 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 |
| Recall Reason | 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. |
| Device Classification | 20210317 |
| Device 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. |
| Center Classification Date | 20210305 |
| Recall Initiation Date | 20210129 |
| Recalling Firm | Getinge Group Logistics America, LLC |
| Initial Notification | Letter |
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