Recall Z-0552-2008 ยท IWX Barrier, Control Panel, X-Ray, Movable
Aadco Medical Inc.
AADCO Rayshield Frame Mounted Overhead X-Ray Barrier; Models: E3051AR S-568, 60 x 80 cm Frame Mounted Barrier with Cut-out, E3051AS S-568HL, 60 x 80 cm Frame Mounted Barrier with Cut-out and lamp, E3051AT S-634, 30 x 40 cm Frame Mounted Barrier, E3051AW S-645S, 40 x 50 cm Frame Mounted Barrier, E3051AY S-634HL, 30 x 40 cm Frame Mounted Barrier with lamp, and E3051AZ S-645SHL, 40 x 50 cm Frame Moun
| Date | Jan 25, 2008 (initiated Nov 1, 2007) |
| Status | Terminated |
| Reason | Screws may become loose from the mounted shield compromising stability |
| Root cause | Device Design |
| Action | AADCO Medical Inc., issued a Product Safety Notification/recall letter to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists and Cardiologists dated 11/1/07. AADCO will perform on site inspections with device tightening or replacement of parts as needed; at no cost the the users |
| Quantity | 324 units |
| Distribution | Worldwide; USA, Canada, Mexico, Brazil, Venezula, Chile, Bermuda, Spain, and Panama |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.