RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 mot

FDA device recall Z-1541-2014 · posted 2014-05-02 · Terminated

Recall details

Recalling firm

Med-Mizer, Inc.

Reason for recall

All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on th

Action taken

On 5/1/14, Med-Mizer sent URGENT: MEDICAL DEVICE RECALL notification to their consignees. Notification included description of the affected product, reason for recall, risk to health, instructions on how to recognize how the device may fail, and instructions for actions to be completed by their consignees. Contact Information: 1-877-867-7365, sales@med-mizer.com, 8am-5pm EST.

Root cause

Process change control

Status

Terminated

Product code

FNL

Quantity affected

191

Distribution

USA (nationwide)

Date initiated

2014-04-18

Date posted

2014-05-02

Date terminated

2016-05-23

Location

Batesville, IN