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U.S. Department of Health and Human Services

Class 2 Device Recall CHAMPION Medical Recliner, AC Powered with heat and massage

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 Class 2 Recall
CHAMPION Medical Recliner, AC Powered with heat and massage
see related information
Date Posted August 17, 2013
Recall Status1 Terminated on January 09, 2014
Recall Number Z-1980-2013
Recall Event ID 65552
Product Classification Chair, Positioning, Electric - Product Code INO
Product CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.
Code Information The following model numbers are affected by this recall: 54PGS636-7JM; 56PLV04-TRL4LJM; 59PT09-F7CJM; 68PT96-TS7JM; 86PT26-TS7JM3; 54PLV04-TRL4LJM; 56PSR20-TS7JM; 59PT19-TFS7PJM3; 85PSR12-TS7JM3; 86PT45-T7KJM; 54PSR20-TS7JM; 56PT21-TS7JM; 65PEV943X-TS7JM3; 85PSR30-TS7JM3; 89PCHA06-TFS7HJM; 54PT26-TS7CJM3; 56PT26-TS7CJM3; 65PFS26-TS7JM; 85PSU103-TS7JM; 89PEV921X-TFS7HPJM3; 54PT45-NJM 56PT45-NJM 65PSH12-S7JM 85PT09-TS7JM3 89PFS04-TFS7HPJM3; 54PT45-TNJM; 56PT45-RNJM; 65PT09-TS7JM; 85PT19-T7JM; 89PFS13-TFS7HPJM3; 54PT45-TS7JM; 58PCHA06-TFS7HJM; 65PT21-TS7JM; 85PT26-TS7JM3; 89PFS15-TFS7HPJM; 54PT56-T7JM; 59PGS493-TFS7HPJM; 66PCHA04-TS7JM; 86PCHA06-TS7JM; 89PFS26-TFS7HPJM3; 54PT96-TS7JM3; 59PGS493-TFS7HPJM3; 66PEV923X-TS7JM3; 86PSU103-TS7JM; 89PFS32-TFS7HPJM3; 56PGS636-7JM; 59PSR12-FS7JM3; 66PFS26-TS7JM; and 86PT09-TS7JM3.
Recalling Firm/
Manufacturer
Invacare Corporation
1200 Taylor St
Elyria, Ohio 44035-6248
Manufacturer Reason
for Recall
There is a possibility of elevated temperatures in the seat pad. In addition, the hospital cord set does not agree with the labeling (information in manual).
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Champion Manufacturing plans to initiate this recall within approximately 10 business days after the submission of this report through a phone campaign and notification letters.
Quantity in Commerce 285 units
Distribution Nationwide distribution: USA including states of: CA, FL, IN, MN, NJ, NY, OH, RI, SC, SD, TX, and VA.
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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