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U.S. Department of Health and Human Services

Class 2 Device Recall AADCO Rayshield

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 Class 2 Recall
AADCO Rayshield
see related information
Date Posted January 25, 2008
Recall Status1 Open
Recall Number Z-0552-2008
Recall Event ID 45888
Product Classification Barrier, Control Panel, X-Ray, Movable - Product Code IWX
Product 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
Code Information Serial Numbers: 03028006 03028007 03028008 03029004 03029005 03029011 03037001 03050001 03050002 03050006 03055001 03055002 03057030 03063006 03071001 03073001 03078007 03083043 03086001 03087023 03097003 03098001 03099001 03101001 03104001 03113001 03114001 03114002 03118001 03126002 03132001 03134001 03135002 03140001 03147002 03149002 03154001 03154001 03156004 03160003 03160004 03167003 03168002 03178001 03188001 03188003 03197001 03197002 03240002 03240003 03241001 03276004 03281001 03287001 03287002 03287003 03288003 03301007 03316001 03316002 03316003 03343006 03343010 03346001 03346002 03349001 03349002 03357003 03357004 03357005 03357006 03363001 04006001 04014004 04020001 04020003 04026001 04029001 04033001 04033003 04034001 04034003 04035001 04042001 04044001 04050001 04050002 04050003 04062001 04064001 04065001 04068001 04068002 04069003 04069006 04075001 04076001 04084125 04104001 04118001 04128001 04131001 04131002 04132001 04138001 04138002 04139001 04142001 04154002 04163001 04163002 04173005 04174001 04189001 04196001 04208001 04212002 04222001 04223001 04226003 04229001 04229004 04229006 04240001 04243001 04252001 04257001 04267001 04267002 04268001 04278001 04279001 04288001 04294005 04294007 04303001 04308001 04308003 04313001 04317001 04317002 04327001 04327002 04328004 04338001 04342001 04342002 04343002 04344001 04344004 04344011 04344012 04349001 04350006 04352001 04356002 04362005 04365001 04365002 05004001 05039001 05040003 05041004 05041005 05046001 05054002 05063009 05070001 05073002 05075001 05075003 05082004 05083002 05088003 05096001 05096002 06024006 06026001 06032001 06038001 06039001 06039002 06046003 06046004 06055004 06058001 06079001 06082001 06097001 06100001 06100002 06100003 06100005 06100006 06102003 06103001 06103002 06110001 06115001 06128001 06130001 06136001 06136002 06136003 06143003 06151001 06151002 06151004 06156001 06165002 06187003 06206001 06213001 06213002 06213003 06216004 06228001 06228003 06229003 06235001 06235002 06237002 06241001 06248001 06256002 06256005 06264001 06268001 06268003 06268004 06270002 06271001 06277002 06317001 06318001 06318004 06325001 06326002 06334001 06335004 06340002 07010004 07010005 07015001 07015002 07044001 07047003 07058001 07059001 07061001 07072001 07073001 07080001 07081011 07085002 07099001 07099002 07142001 07169001 07178002 07226001and 0727400 (not inclusive data goes back to 2003)
Recalling Firm/
Manufacturer
Aadco Medical Inc.
2279 Vermont Rte. 66
Randolph, Vermont 05060
For Additional Information Contact Darrel J Lasell
802-728-3400
Manufacturer Reason
for Recall
Screws may become loose from the mounted shield compromising stability
FDA Determined
Cause 2
DESIGN: 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 in Commerce 324 units
Distribution Worldwide; USA, Canada, Mexico, Brazil, Venezula, Chile, Bermuda, Spain, and Panama
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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