Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the ent...
FDA Device Recall #Z-1279-2022 — Class I — May 2, 2022
Recall Summary
| Recall Number | Z-1279-2022 |
| Classification | Class I — Serious risk |
| Date Initiated | May 2, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Getinge Usa Sales Inc |
| Location | Wayne, NJ |
| Product Type | Devices |
| Quantity | 47 units US |
Product Description
Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
Reason for Recall
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
Distribution Pattern
US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia
Lot / Code Information
UDI-DI: 07325710010457 Serial Numbers: 50012, 50013, 50014, 50015, 50016, 50017, 50030, 50031, 50033, 50034, 50035, 50036, 50037, 50038, 50039, 50040, 50041, 50042, 50043, 50046, 50047, 50048, 50051, 50052, 50053, 50054, 50055, 50056, 50057, 50058, 50059, 50060, 50061, 50062, 50069, 50070, 50071, 50072, 50073, 50074, 50084, 50085, 50086, 50087, 50088, 50089, 50090, 50091, 50092, 50093, 50094, 50096, 50097, 50108, 50109, 50110, 50111, 50132. (Note: UDI was corrected July 7, 2022)
Other Recalls from Getinge Usa Sales Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1074-2025 | Class I | Vaporizer Sevoflurane, Quik-Fil. Model Number: ... | Jan 15, 2025 |
| Z-0462-2025 | Class II | MEERA CL mobile operating table - Designed for ... | Oct 3, 2024 |
| Z-0463-2025 | Class II | MEERA CL mobile operating table - Designed for ... | Oct 3, 2024 |
| Z-0458-2025 | Class II | MEERA CL mobile operating table - Designed for ... | Oct 3, 2024 |
| Z-0460-2025 | Class II | MEERA CL mobile operating table - Designed for ... | Oct 3, 2024 |
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.