Recall Z-1541-2014 ยท FNL Bed, Ac-Powered Adjustable Hospital
Med-Mizer, Inc.
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.
| Date | May 2, 2014 (initiated Apr 18, 2014) |
| Status | Terminated |
| Reason | 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 | 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, sales@med-mizer.com, 8am-5pm EST. |
| Quantity | 191 |
| Distribution | USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.