Recall Z-0063-2007 ยท LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Invacare Corporation
AC-powered Adjustable Hospital Bed. (ICCG Bed) Affected Model numbers: IH820-3MDLX, IHSC900DLX, IH820-3MDLX-QS, IH820-3MPDLX-QS, SC900-80WDLX-QSP, SC900-80PDLX-QSP, IH820-3MDLX-AE-333PS, SC90080GDLX-AE-366PA, SC90080GDLX-AE-333PS, IH820-3MDLX-AE-366PS, IH820-3MDLX-AE-333PA, IH820-3MDLX-AE-366PA and SC90080GDLX-AE-366PS
| Date | Oct 24, 2006 (initiated Sep 27, 2006) |
| Status | Terminated |
| Reason | The incorrect caution label that describes washing instructions was applied to beds distributed in the US, i.e. the specified label is P/N 1116654 (English translation); the label that was used is P/N 1119165 (French translation). |
| Root cause | Other |
| Action | E-mails and letters regarding this correction provided to the consignees on September 27, 2006, and to appropriate Invacare personnel for information purposes. Consignees are being notified via delivery of a field correction package. Once the packages have been sent, a notice will be posted on the Invacare website. A follow-up contact will be scheduled in 2 to 3 months to try to reach those who have not returned their tracking sheet indicating completion of their corrective action. |
| Quantity | 2065 |
| Distribution | United States and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.