Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1541-2014Class II

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

Med-Mizer, Inc. / initiated 2014-04-18 / Terminated / root cause: manufacturing process

Med-Mizer, Inc. began a recall of RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1541-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Med-Mizer, Inc.
Product
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
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
Root cause tag
manufacturing process
FDA root cause
Process change control
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.
Quantity in commerce
191
Distribution
USA (nationwide)
Product codes and lots
Model 762: 300000-300191 Model 763: 200000 Model 763A: 400000-40103

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1541-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1541-2014Class IITerminatedVoluntary: Firm initiated
Z-1542-2014Class IITerminatedVoluntary: Firm initiated
Z-1543-2014Class IITerminatedVoluntary: Firm initiated