Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0...
FDA Device Recall #Z-0484-2021 — Class II — November 12, 2020
Recall Summary
| Recall Number | Z-0484-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 12, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hill-Rom Manufacturing, Inc. |
| Location | Saint Paul, MN |
| Product Type | Devices |
| Quantity | 67 devices |
Product Description
Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport.
Reason for Recall
Under certain conditions, there is a risk for fire.
Distribution Pattern
US Nationwide distribution including in the states of AR, AZ, CA, DE, FL, IL, IN, KY, MN, NC, NM, NV, NY, OH, OK, TX, UT, VA, VT, WI.
Lot / Code Information
Devices with the following Serial Numbers: 120210000731, L2004034-154, 120210000716, L1905010-080, 120210000750, 120190000086, 120190001268, 120210000885, 120190000724, 120190001234 120190001276, 120210000732, L1911019-029, 120210000761, L2002011-094, 120210000747, 120210000760, 120210000730, 120210000734, 120190000076 120190000079, 120190000081, 120190000090, 120190000714, 120190000722, 120190000074, 120190000077, 120190000728, 120210001608, 120210000742, 120210000755, L2001006-040, 120210000733 L1911019-035, 120210000744, 120210001613, 120210001614, 120210000714 L1903102-021, 120190001269, 120210000743, 120210000741, L1912010-015, 120210000753, 120210000739, 120190000088, 120190000711, 120190000718 120190001264, 120210001615, L1903102-012, L2001016-045, 120190000078 120190000089, 120190001266, 120210000884, 120190000091, 120190000093, 120190000707, 120210000729, L1903103-006, L1912010-005 L1912013-033, L2002040-095, L2002040-064, L2002040-093, L2003004-106
Other Recalls from Hill-Rom Manufacturing, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0192-2018 | Class II | Monarch Airway Clearance System, Model 1000, Pr... | Sep 15, 2017 |
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.