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U.S. Department of Health and Human Services

Class 2 Device Recall Lift Chairs

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  Class 2 Device Recall Lift Chairs see related information
Date Initiated by Firm June 07, 2004
Date Posted November 19, 2004
Recall Status1 Terminated 3 on August 10, 2006
Recall Number Z-0212-05
Recall Event ID 29344
510(K)Number K953342  K931349  K852864  K821827  
Product Classification Chair, Positioning, Electric - Product Code INO
Product Lift Chairs. Electric Positioning Chair.
Code Information Model Numbers: C20, C30, GL358S, GL358L, TMR58, TMR540, TMR560, TMR570T, TMR571, TMR585, DMR670, TMR805, and TMR450.
Recalling Firm/
Manufacturer		 Pride Mobility Products Corp
182 Susquehanna Avenue
Exeter PA 18643
For Additional Information Contact Michael Zablocky
570-655-5574 Ext. 1410
Manufacturer Reason
for Recall		 The heating pad on these Lift Chairs may tear at the entry point causing a short and/or overheating, which can damage the chair.
FDA Determined
Cause 2		 Other
Action The recalling firm sent a Safety Alert notification to their direct accounts on 5/14/04 informing them of the problem. The direct accounts were instructed to locate the end user and inform them of the problem. Once the chair has been located the direct account is to contact the recalling firm for a replacement and return the recalled chair.
Quantity in Commerce 532 units
Distribution The recalled product was distributed through dealers nationwide. The affected states are as follows: AL, AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, OH, OK, MA, MD, MI, MN, MO,MS, NC, ND, NE, NH, NJ, NM, NV, NY, PA, SC, TN, TX, UT, VA, VT, WA, and WV . There is one government account in FL.
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.
510(K) Database 510(K)s with Product Code = INO and Original Applicant = PRIDE HEALTH CARE EQUIPMENT
510(K)s with Product Code = INO and Original Applicant = PRIDE HEALTH CARE, INC.
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