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Recall Observatory FDA recall evidence

Device product

Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.

Z-0785-2013

September 10, 2012

Class II

Product summary

Firm
Invacare Corporation
Event
Event 64044
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-0785-2013

Official wording

Reason: The potential exists for the wheel to rotate freely despite engagement of hub brake.

Code information: Model #3G, Serial numbers: 12GE003750, 12GE003554 and 12HE001766.

Distribution pattern: US Nationwide Distribution including the states of CA & MT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The potential exists for the wheel to rotate freely despite engagement of hub brake.