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 Mounted Barrier with lamp, AADCO Medical, Inc., Randolph, VT. 05060
FDA Recall Z-0552-2008 · Posted 2008-01-25
Recalling FirmAadco Medical Inc.
Recall StatusTerminated
Product CodeIWX
Date Initiated2007-11-01
Date Terminated2012-05-02
Product Quantity324 units
Reason for Recall
Screws may become loose from the mounted shield compromising stability
Firm 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
Root Cause
Device Design
Distribution Pattern
Worldwide; USA, Canada, Mexico, Brazil, Venezula, Chile, Bermuda, Spain, and Panama
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.