Recall Z-1172-2007 ยท FSA Lift, Patient, Non-Ac-Powered
The Sisus Corporation
Non-AC-powererd Patient Lifts for assisting patients when bathing and toileting-sold under names "Bath Helper" and "Shower Helper" , Sisus Corporation, Santa Cruz, CA 95062.
| Date | Aug 17, 2007 (initiated Jun 1, 2007) |
| Status | Terminated |
| Reason | Poor welding may cause the device(s) to fail, which may result in the user, falling in the bathroom and/or a lack of assistance with bathing or toileting. |
| Root cause | Device Design |
| Action | On 6/8/2007, a letter was sent to all dealers and each direct account customer/user followed by a phone call to ensure the notification letter was received. Customers were instructed to discontinue use of the devices pending receipt of modification kits/ instructions to be shipped priority overnight. The firm plans to call customers/dealers to support them with the installations and ensure smooth implementation. Dealers were instructed to conduct recall to the user level. |
| Quantity | approximately 100 units have been distributed. |
| Distribution | Nationwide Distribution including states of PA, TX, NY, MI, AL, FL, CA, OH, CT, WA, MD, OR, NC, NH, VT, IL, CO, HI, LA, GA, TN, OK, MA, KS, SC, ME, GA, MN, IN, and DE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.