AC-powered Adjustable Hospital Bed. (ICCG Bed) Affected Model numbers: IH820-3MDLX, IHSC900DLX, IH820-3MDLX-QS, IH820-3M

FDA device recall Z-0063-2007 · posted 2006-10-24 · Terminated

Recall details

Recalling firm

Invacare Corporation

Reason for recall

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).

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LLI

Quantity affected

2065

Distribution

United States and Canada.

Date initiated

2006-09-27

Date posted

2006-10-24

Date terminated

2009-10-05

Location

Sanford, FL