Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1980-2013Class II

CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a...

Invacare GmbH / initiated 2013-06-18 / Terminated / root cause: manufacturing process

Invacare Corporation began a recall of 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... on . FDA classified it as Class II and gives the reason as "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)". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1980-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Invacare GmbH
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.
Product code
INO Chair, Positioning, Electric
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).
Root cause tag
manufacturing process
FDA root cause
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.
Product codes and 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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1980-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1980-2013Class IITerminatedVoluntary: Firm initiated