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U.S. Department of Health and Human Services

Class 2 Device Recall Midland DeluxeMat Platform with Adjustable Backrest

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  Class 2 Device Recall Midland DeluxeMat Platform with Adjustable Backrest see related information
Date Initiated by Firm January 25, 2006
Date Posted July 12, 2006
Recall Status1 Terminated 3 on April 01, 2007
Recall Number Z-1209-06
Recall Event ID 34510
Product Classification Wood tables Plinth - Product Code INT
Product Midland Deluxe Mat Platform with Adjustable Backrest Model C5522-30A, B, and C,
Code Information Serial number prefixess 2509 throuth 2511
Recalling Firm/
W.68 N.158 Evergreen Blvd.
Cedarburg WI 53012
Manufacturer Reason
for Recall
There have been reports of structural failure on the skirt of select tables. The risk to patients presented by possible structural failure of the skirt of the table is a slow collapse of the plinth which could cause the patient to be displaced.
FDA Determined
Cause 2
Action Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
Quantity in Commerce 831 devices total
Distribution Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.