Agency classClass IIOur severity:High FDA (Devices)·Z-1980-2013·Announced 2013-08-28

Invacare Recalls CHAMPION Medical Recliners Due to Heat and Labeling Issues

Invacare is recalling 285 CHAMPION Medical Recliners because the seat pad may reach elevated temperatures and the cord set labeling is incorrect.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of elevated temperatures (burn hazard) on a medical device, which fits the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Invacare Corporation is recalling 285 units of the CHAMPION Medical Recliner, an AC-powered chair with heat and massage features. The recall covers specific model numbers distributed nationwide in the United States, including California, Florida, Indiana, Minnesota, New Jersey, New York, Ohio, Rhode Island, South Carolina, South Dakota, Texas, and Virginia.

The recall was initiated because there is a possibility of elevated temperatures in the seat pad. Additionally, the hospital cord set does not match the information provided in the product manual. The recliners are designed to provide heat and massage after surgery.

Consumers who have these specific model numbers should stop using the product and contact Invacare Corporation for instructions on how to proceed with the recall.

The recalled product

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.
Manufacturer: Invacare Corporation
Category: Medical Device — Recliner
Hazard: burn-injury
mis-labeling
Affected units: 285

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Same manufacturer · Invacare Corporation

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Same hazard · burn injury