Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.

FDA Recall Z-1542-2014 · Posted 2014-05-02

Recalling FirmMed-Mizer, Inc.
Recall StatusTerminated
Product CodeFNK
Date Initiated2014-04-18
Date Terminated2016-05-23
Product Quantity1

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

Firm Action

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, [email protected], 8am-5pm EST.

Root Cause

Process change control

Distribution Pattern

USA (nationwide)

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑