Recall Z-0727-2007 ยท FSA Lift, Patient, Non-Ac-Powered
Joerns Healthcare Inc.
Sunrise Medical-Hoyer Advance Patient Lifts (Portable and Folding Patient Lift) Sunrise Medical, Inc.
| Date | Apr 7, 2007 (initiated Feb 21, 2007) |
| Status | Terminated |
| Reason | Unapproved Design Change (by base supplier) consisting of a reduction in the number of mast-to-base welds (from four welds to two welds). |
| Root cause | Other |
| Action | Recall initiated by letter dated 2/21/2007. Sunrise Medical will schedule onsite appointments to complete the base replacement. |
| Quantity | 581 units |
| Distribution | Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.