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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 Device Recall CHAMPION Medical Recliner, AC Powered with heat and massagesee related information
Date Initiated by FirmJune 18, 2013
Date PostedAugust 17, 2013
Recall Status1 Terminated 3 on January 09, 2014
Recall NumberZ-1980-2013
Recall Event ID 65552
Product Classification Chair, positioning, electric - Product Code INO
ProductCHAMPION 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 OH 44035-6248
For Additional Information Contact
440-329-6595
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		Process control
ActionChampion 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 Commerce285 units
DistributionNationwide distribution: USA including states of: CA, FL, IN, MN, NJ, NY, OH, RI, SC, SD, TX, and VA.
Total Product Life CycleTPLC 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.
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