Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of...
FDA Device Recall #Z-0549-2019 — Class II — November 16, 2018
Recall Summary
| Recall Number | Z-0549-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 16, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Invacare Corporation |
| Location | Elyria, OH |
| Product Type | Devices |
| Quantity | 73,703 units |
Product Description
Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lift and transfer a patient from one surface to another, as from a bed to a wheelchair. The device includes straps and a sling to support the patient.
Reason for Recall
Invacare has identified via customer complaints, the potential for the mounting bolt connecting the caster to the base frame of the patient lifts to become loose. Loose hardware can cause wear to the hardware and housings. If left unresolved, the caster may separate from the base of the lift causing the Lift to tilt and a patient fall. Failure does not occur right away but happens over time if the lift is not properly maintained. Patient falls are inherently dangerous and may result in a range of injuries that are dependent on physical condition of the patient and the nature of the fall. When injuries occur, they are typically non-serious injuries such as bruising, lacerations, or abrasions. In rare cases, more serious injuries such as bone fracture, head trauma, or death can occur. For caregivers using the lift, attempts to manually stabilize a lift if it becomes unstable could result in sprains, serious back injuries, or bone fractures.
Distribution Pattern
Worldwide Distribution: US (Nationwide) and countries of: Canada, Colombia, Germany, Guam, India, Northern Mariana Islands, Philippines and South Africa.
Lot / Code Information
Serial numbers ranging between 09FSZ590001 to 16ESZ104075. Specifically, serial numbers with the following starting values (see below). Each consignee will be receiving an impacted units list, which will include full serial numbers for the units that they have purchased: 10ASZ 11ASZ 12ASZ 13ASZ 14ASZ 15ASZ 16ASZ 10BSZ 11BSZ 12BSZ 13BSZ 14BSZ 15BSZ 16BSZ 10CSZ 11CSZ 12CSZ 13CSZ 14CSZ 15CSZ 16CSZ 10DSZ 11DSZ 12DSZ 13DSZ 14DSZ 15DSZ 16DSZ 10ESSZ 11ESSZ 12ESSZ 13ESSZ 14ESSZ 15ESSZ 16ESSZ 09FSZ 10FSZ 11FSZ 12FSZ 13FSZ 14FSZ 15FSZ 09GSZ 10GSZ 11GSZ 12GSZ 13GSZ 14GSZ 15GSZ 09HSZ 10HSZ 11HSZ 12HSZ 13HSZ 14HSZ 15HSZ 09ISZ 10ISZ 11ISZ 12ISZ 13ISZ 14ISZ 15ISZ 09JSZ 10JSZ 11JSZ 12JSZ 13JSZ 14JSZ 15JSZ 09KSZ 10KSZ 11KSZ 12KSZ 13KSZ 14KSZ 15KSZ 09LSZ 10LSZ 11LSZ 12LSZ 13LSZ 14LSZ 15LSZ
Other Recalls from Invacare Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1251-2024 | Class II | Invacare Homecare Series Bed and Invacare G-Ser... | Jan 22, 2024 |
| Z-2445-2023 | Class II | DOLOMITE GLOSS ROLLATOR - intended to support d... | Jun 15, 2023 |
| Z-1369-2022 | Class III | Invacare Platinum 5NXG Oxygen Concentrator, Mod... | Jun 10, 2022 |
| Z-1130-2022 | Class II | Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG... | Mar 30, 2022 |
| Z-0445-2022 | Class II | Invacare TDX SP2 with LiNX Gyro Power Wheelchai... | Nov 12, 2021 |
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.