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Class 2 Device Recall ReliaMed Deluxe Portable Adjusting Table |
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Date Initiated by Firm |
April 23, 2010 |
Date Posted |
August 26, 2010 |
Recall Status1 |
Terminated 3 on February 16, 2012 |
Recall Number |
Z-2288-2010 |
Recall Event ID |
55772 |
Product Classification |
Chair and table, medical - Product Code FPS
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Product |
ReliaMed Deluxe Portable Adjusting Table. Product is a medical table used on patients for massage and chiropractic treatment. |
Code Information |
The table do not bear lot or serial numbers; however there are two device identification numbers representative of two different colors. ZZRNT100BL (blue) ZZRMT100BLK (black) |
Recalling Firm/ Manufacturer |
MDC Acquisition Co. 8595 Milliken Ave Ste 101 Rancho Cucamonga CA 91730-4942
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For Additional Information Contact |
909-948-2255
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Manufacturer Reason for Recall |
Two complaints were received of the vinyl-covered, padded, plywood table surface breaking near the foot end.
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FDA Determined Cause 2 |
Component design/selection |
Action |
"Urgent: Medical Device Recall" letters were sent to consignees from Milliken Medical and Meyer Distributing Company in April 2010 describing the issue. They instructed their customers to immediately stop use of the table. customers were instructed to return the tables to the firm with an enclosed Recall Form for future replacement, or for replacement with a comparable table from another menufacturer at no cost, or for refund of the original cost of the device. Consignees may contact Meyer Distributing Company at 800-472-4221 and Milliken Medical at 800-532-1356. |
Quantity in Commerce |
265 Tables |
Distribution |
Worldwide distribution: USA, including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA and WI, and the country of Canada. |
Total Product Life Cycle |
TPLC Device Report
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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.
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