Recall Z-0549-2019 ยท FSA Lift, Patient, Non-Ac-Powered
Invacare Corporation
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.
| Date | Nov 16, 2018 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| Action | On November 16, 2018, the firm, INVACARE, distributed "URGENT - MEDICAL DEVICE FIELD ACTION" letters with an attached Technical Bulletin to providers to inform them of the product issue, problems and actions to be taken. Providers are instructed to do the following: 1. Review the included Technical Service Bulletin. 2. Inspect your existing stock for loose fasteners or hardware as required in the user manual. 3. Tighten any loose hardware after inspecting for damage that require replacement of the Lift base. 4. You are responsible for ensuring that this field action is conducted to the cust |
| Quantity | 73,703 units |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Canada, Colombia, Germany, Guam, India, Northern Mariana Islands, Philippines and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.