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Recall Observatory FDA recall evidence

Device product

Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.

Z-2402-2016

March 15, 2016

Class II

Product summary

Firm
Invacare Corporation
Event
Event 73577
Status
Terminated
Classification
Class II
Quantity
1,011 units
Official record key
device-enforcement:Z-2402-2016

Official wording

Reason: The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials.

Code information: Model #'s:1104343 & 1104345

Distribution pattern: US Nationwide Distribution including DC and PR. Internationally Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials.