Recall Z-1980-2013
Invacare Corporation · initiated June 18, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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.
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: Process control
Action taken
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.
Details
- Recall number
- Z-1980-2013
- Initiated
- June 18, 2013
- Posted by FDA
- August 17, 2013
- Terminated
- January 9, 2014
- Product code
- INO – Chair, Positioning, Electric
- Quantity
- 285 units
- Distribution
- Nationwide distribution: USA including states of: CA, FL, IN, MN, NJ, NY, OH, RI, SC, SD, TX, and VA.
- Recalling firm
- Invacare Corporation, Elyria, OH