FDA-Device2017-10-11Class II
IVEA Product Part Number 16100 Model 500A
Firefly Medical, Inc.
Hazard
The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.
Sold states
United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE
Affected count
570 units
Manufactured in
320 E Vine Dr Ste 312, N/A, Fort Collins, CO, United States
Products
IVEA Product Part Number 16100 Model 500A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3239-2017Don't want to check this manually?
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