Recall Z-1185-2017 ยท LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Invacare Corporation
Junction Box - 1104343 and 1193560
| Date | Dec 2, 2016 |
| Status | Terminated |
| Reason | A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire. |
| Root cause | Component design/selection |
| Action | All customers were notified via letter with return receipt. This notification will include a provider letter, provider response card, impacted unit list and a consumer letter. Consignees will be instructed conduct sub-recalls as necessary. Follow-up telephone calls will be made to nonresponders. |
| Quantity | 161 units |
| Distribution | Products were distributed in the following states: AK, AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. No foreign accounts |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.