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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Event Detail

Event ID 65552
Product Type Devices
Status Ongoing
Recalling Firm Invacare Corporation
City Elyria
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-18
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide distribution: USA including states of: CA, FL, IN, MN, NJ, NY, OH, RI, SC, SD, TX, and VA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class II 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). 285 units Z-1980-2013