Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while contro...

FDA Device Recall #Z-1181-2021 — Class II — January 29, 2021

Recall Summary

Recall Number Z-1181-2021
Classification Class II — Moderate risk
Date Initiated January 29, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Getinge Group Logistics America, LLC
Location Wayne, NJ
Product Type Devices
Quantity 144 units

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.

Distribution Pattern

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.

Lot / Code Information

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.

Other Recalls from Getinge Group Logistics America, LLC

Recall # Classification Product Date
Z-1296-2021 Class II Operating Table System Feb 11, 2021
Z-1124-2021 Class II Getinge CM320 Series Washer Disinfector - Produ... Dec 21, 2020
Z-0092-2021 Class II Servo-i Ventilator, Part No. 6487800, UDI Code ... Sep 17, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.